• DecorMatters
  • $108,380.00 -167,060.00/year*
  • Brighton, MA
  • Executive Management
  • Full-Time
  • 413 Market St

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When an opportunity in which you are interested becomes available, please submit your resume and cover letter with job code and salary requirements to the address below. All submissions will be evaluated. Interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for one year. E-mail All e-mails should include the specific job code in the subject line, resumes should be attached as PDF??s and sent to careers@. No phone calls please. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve Position Summary:We are seeking a Senior Accounts Payable (A/P) Coordinator to support all aspects of the accounts payable cycle. This position will report to the Accounts Payable Specialist and be located in the Waltham, MA office. Key Responsibilities: ? Prioritize, manage and process A/P entries for daily, weekly, monthly functions ? Review and audit expense reports for processing, adhering to company travel policy ? Input expense payable requests for reimbursement ? Process purchase orders into AP system upon complete review of approved and signed contract and audit of account coding ? Monitor the Accounts Payable inbox in Outlook and resolve invoicing requirements ? Obtain proper approvals for PO, invoices and payments ? Resolve invoice and payment disputes, including communication with vendors, as needed ? Distribute payments to include check, wires, ACH/credit card processing ? Maintain and reconcile vendor records and accounts ? Process 1099??s ? Assist team with GL and bank reconciliation, as needed ? Work with Accounting team on other accounting related projects Required Qualifications: ? Bachelor??s Degree and 2+ years?? experience in accounts payable preferably in a biotech ? Working knowledge of Microsoft Office Suite (Outlook, Word and Excel) ? Experience with NetSuite and Concur, a plus ? Requires attention to detail and compliance with strict deadlines ? Strong organizational skills and ability to prioritize and multi-task ? Ability to effectively communicate, both verbally and in writing ? Experience working in a fast-paced, high-growth environment Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a ??switched off?? or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We offer an outstanding culture focused on: ? Providing a collaborative and energized work environment ? A diverse and multi-disciplinary workforce ? Dedicated and talented people who are passionate about achieving excellence in all they do ? A commitment to the patients we serve We are seeking a Manager/Sr. Manager GMP/GDP Quality Assurance (DS & P & L) to provide expertise for the development and commercialization of Deciphera??s products in compliance with relevant US, EU and ICH requirements. The primary responsibility of this position will be to ensure proper QA oversight and collaboration with Deciphera??s Drug Substance (DS) and Packaging & Labeling (P&L) partners. This position will report to the Director, GMDP & GLP Quality and be located in the Waltham, MA office. Key Responsibilities: ? Assure compliance (internally and externally) with 21 CFR 210/211, 312, EudraLex Vol. 4 (including relevant parts and annexes) and ICH. ? Provide GMP oversight and management of daily quality related tasks and priorities of the clinical and commercial DS and P&L partners. ? Review and Approve Master Batch Production & Packaging Records and Executed Batch Production & Packaging Records. ? Responsible for all DS and P&L material disposition. ? Internal Quality lead for DS and P&L partner change controls, deviations, and investigations. ? Collaborate and support with internal stakeholders, along with DS and P&L partners on validation and technology transfer activities. ? Establish and maintain strategic business partnerships to ensure corporate deliverables are met. ? Create organizational procedures and processes for clinical and commercial programs. ? Develop, review and approve relevant Technical Quality Agreements. ? Assist in internal audit program and regulatory inspections. ? Support QP release activities. ? Review pertinent CMC sections of regulatory submissions. Required Qualifications: ? B.S. degree in life sciences, chemistry or equivalent. ? 5+ years of GMP Quality experience, with at least 3 years managing external partners. ? Ability to manage multiple projects in a dynamic environment. ? Experience working with drug substance and packaging partners. ? A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties. ? Excellent interpersonal skill with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments. ? A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations and business needs. ? Proven track-record of leadership and building relationships with internal and external partners. ? Experience with using risk-based principles and decision making to ensure compliance at all stages of development. ? Ability to travel ~15% domestically and internationally. ? Must be authorized to work in the US. Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a ??switched off?? or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We offer an outstanding culture focused on: ? Providing a collaborative and energized work environment ? A diverse and multi-disciplinary workforce ? Dedicated and talented people who are passionate about achieving excellence in all they do ? A commitment to the patients we serve We are seeking a Manager/Sr. Manager GMP/GDP QA (DP) to provide expertise for the development and commercialization of Deciphera??s products in compliance with relevant US, EU and ICH requirements. The primary responsibility of this position will be to ensure proper QA oversight and collaboration with Deciphera??s Drug Product (DP) partners. This position will report to the Director, GMDP & GLP Quality and be located in the Waltham, MA office. Key Responsibilities: ? Assure compliance (internally and externally) with 21 CFR 210/211, 312, EudraLex Vol. 4 (including relevant parts and annexes) and ICH. ? Provide GMP oversight and management of daily quality related tasks and priorities of the clinical and commercial DP partners. ? Review and Approve Master Batch Production Records and Executed Batch Production Records. ? Responsible for all DP material disposition. ? Internal Quality lead for DP partner change controls, deviations, and investigations. ? Collaborate with and support internal stakeholders, along with DP partners on validation and technology transfer activities. ? Establish and maintain strategic business partnerships to ensure corporate deliverables are met. ? Create organizational procedures and processes for clinical and commercial programs. ? Develop, review and approve relevant Technical Quality Agreements. ? Assist in internal audit program and regulatory inspections. ? Support QP release activities. ? Review pertinent CMC sections of regulatory submissions. Required Qualifications: ? B.S. degree in life sciences, chemistry or equivalent. ? 5+ years of GMP Quality experience, with at least 3 years managing external partners. ? Experience working with small molecule drug products. ? Ability to manage multiple projects in a dynamic environment. ? A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties. ? Excellent interpersonal skill with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments. ? A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations and business needs. ? Proven track-record of leadership and building relationships with internal and external partners. ? Experience with using risk-based principles and decision making to ensure compliance at all stages of development. ? Ability to travel ~15% domestically and internationally. ? Must be authorized to work in the US. Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve Position Summary:We are seeking an Associate Director/ Director, Analytical Development to have overall responsibility for leading and managing early-stage CMC development activities related to analytical characterization of products/processes and the development, qualification, transfer and validation of analytical methods for QC release and stability testing of small-molecule drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components. Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for analytical CRO/CDMO selection and oversight. The successful candidate will also assume a key leadership role in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs. This position will report to the Vice President, Chemical and Pharmaceutical Development and be located in the Lawrence, KS office. Key Responsibilities: ? Working through CDMOs, Lead and manage analytical activities for GMP and non-GMP manufacture of drug substance and drug product, including method development/transfer, method validation, release testing, reference standard characterization, investigations for OOS.OOT results, etc. ? Oversee stability operations and reference standard management for early clinical assets. ? Develop and maintain strong relationships with CRO/CDMO business partners. ? Review/approve technical reports, controlled GMP documents (e.g., analytical methods and associated validation protocols, specifications, change controls, LIRs, SOPs, etc.) and incorporate CMC content for Module 3 CTDs. ? As needed, Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities. Required Qualifications: ? A B.S./M.S. degree in analytical chemistry or related life sciences discipline with at least 10 years of experience in small-molecule pharmaceutical product development or commercialization (or) a PhD with 5 + years of relevant experience. ? Experience and in depth understanding of routine instrumental methods: HPLC, GC, Mass Spec ? Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills. ? Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints. ? Strong decision-making skills and ability to influence internal and external stakeholders. ? Thorough knowledge of the drug development process and ICH requirements for IND/IMPD filings. Track record of authoring and defending Module 3 CTD content. ? Ability to articulate complex issues and ideas with clarity to enable understanding and decision making. ? Ability to work successfully in a team/matrix environment and independently, as required. ? Ability to travel (10%) to CRO/CDMO domestic and international sites. Preferred Qualifications: ? Prior experience leading and managing small-molecule analytical development in a 100% outsourced environment preferred. Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve Position Summary: We are seeking a Director, Drug Product Development to be responsible for the leadership and management of drug product development and manufacturing activities, including activities at contract research and manufacturing organizations, to support early phase clinical studies. Partnering with drug substance and analytical development teams, this individual will be responsible for the completion of IND-enabling development and drug product manufacturing for small molecule NCEs. The candidate will ensure timely manufacturing of drug product to support early clinical development programs. The Director will further contribute active support for regulatory CMC filings. This position will report to the Vice President, Chemical and Pharmaceutical Development and be located in the Lawrence, KS office. Key Responsibilities: ? Design and implement phase-appropriate drug product formulation development and supply strategies to support Deciphera??s pipeline and early clinical programs ? Serve as primary contact and manage CMOs/CROs in conduct of DP process development, process optimization, scale-up and clinical manufacturing. ? Work closely with chemical and analytical development functions ? Provide critical pre- and post-review of manufacturing batch records and integrate results into CMC regulatory filings ? Author and review regulatory reports/documents such as IND filings, IND updates, product development reports, quality summary, master batch records and other key reports/documents ? Potentially represent company in meetings with regulatory agencies ? Work with CMC senior leadership to create and communicate project strategy, plans and schedules that are aligned with company objectives and portfolio prioritization Required Qualifications: ? Advanced degree (PhD preferred) in scientific or engineering discipline and 10 years of hands-on experience in pharmaceutical industry with drug product development for small molecules ? Experience in solid oral dosage forms. ? Clear written and verbal communication skills. Must be able to communicate effectively with executive leadership, consultants and contract research/manufacturing organizations ? Ability to direct and guide the work of CMOs. ? Understanding of cGMP manufacturing ? Strong project management experience ? Experience in process scale-up and transfer ? Demonstrated ability to multi-task under pressure and ability to prioritize competing activities ? Prior authorship of INDs, IMPDs ? Late stage development and commercialization experience is a plus Preferred Qualifications: ? Familiarity with US and international regulatory CMC guidance and processes ? Prior experience filing NDAs highly desirable ? Excellent computer skills (e.g., Microsoft Office, Excel, Project) ? Strong organizational skills with attention to detail and ability to manage multiple projects at once ? Ability to work both independently and in a team focused environment ? Ability to travel up to 15% to support CDMO relationships/manufacturing Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve Position Summary:We are seeking a Manager/Senior Manager, Clinical Quality Assurance to be responsible for the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Deciphera. The primary responsibilities will be to ensure that both quality and compliance of Deciphera sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices. This position will report to the Associate Director, Quality Assurance and be located in the Waltham, MA office. Key Responsibilities: ? Draft, review or revise Clinical SOPs to assess consistency and compliance with regulatory requirements/internal standards ? Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management ? Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary ? Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation) ? Work directly with CRO??s and other external contractors and collaborators, managing the chain of communication related to GCP compliance ? Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc. ? Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs) ? Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process ? Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents ? Assist and advise with training QA and clinical staff as necessary for GCP ? Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation ? As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board ? Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management ? Assist with inspection readiness, and regulatory inspections as needed Required Qualifications: ? At least 5 years of direct GCP pharmaceutical/biotechnology experience ? Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6R2 ? A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments ? Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments ? The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events ? Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing ? A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs ? Experience with using risk-based principles & decision making to ensure compliance at all stages of development ? Proven track-record of leadership & building relationships with both internal & external customers ? Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve Position Summary:This position may be filled at Associate Director or Director level based on candidate??s skills/experience and will report to the Sr Director, Clinical Research at Deciphera??s corporate headquarters in Waltham, MA. Key Responsibilities: ? Works closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols ? Assists Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts ? Drives the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts ? Drives and integrates clinical contribution to answering regulatory queries and other submissions related to studies ? Monitors real time study data to ensure the integrity of the study and the study data and interacts with investigators and internal and external experts to resolve any study issues as they arise ? Involved in high level data cleaning activities requiring clinical judgment Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs ? Acts as clinical/scientific expert on the products and studies in the therapy area ? Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors ? Works with investigative sites to answer protocol related questions, resolve study conduct and design issues ? May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings Required Qualifications: ? MS in Life Sciences (or BS plus equivalent experience); Pharm D, or BSN or other equivalent clinical qualifications ? 8 years?? experience in product & clinical development (Clinical Scientist role) in Biotech or Pharmaceutical company ? Understanding of GCP, ICH and regional/local regulations ? Experience in both early and late phase development ? Medical knowledge and experience in clinical development/ operations (Oncology preferred) ? Experience reviewing clinical data outputs ? Ability to perform literature searches and to utilize library services ? Ability to conduct basic data analyses using Excel and other tools ? Basic understanding of biostatistics to allow effective interaction with biostatistics expert ? Requires approximately 15-30% travel Preferred Qualifications: ? Teaching capability ? Excellent communication skills, both verbal and in writing ? Strong presentation skills ? Team player ? Ability to proactively predict issues and solve problems ? Ability to drive decision-making within a multi-disciplinary, multi-regional matrix team ? Diplomacy and positive influencing abilities ? Experience building data presentation plans Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve Position Summary: We are seeking an Associate Director, SAS Programming to join our biometrics group. This position will report to the Senior Director, Head of Biometrics and be located in the Waltham, MA office. Key Responsibilities: ? Serves as a lead programmer for a compound or key NDA related activities ? Efficiently manage CROs to meet timelines and expectation of quality ? Works collaboratively with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines ? Programs for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards ? Programs TLFs for implementation of the statistical analysis plans and for AdHoc analysis in clinical trial of all phases ? Performs programming QC on TLFs ? Tracks clinical trial milestones and works with vendors for statistical reporting deliverables. ? Maintains records for all assigned projects and archiving of trial/project analysis and associated documentation ? Understands and performs in accordance with regulatory standards, and drug development principles ? Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package ? Plans, develops, tests, and documents SAS macros for programming efficiency Required Qualifications ? 8+ years in statistical programming within the Pharmaceutical industry ? Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions ? Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development ? Ability to define and implement CDISC compliant SDTM and ADaM data and specifications ? Oncology experience is a plus Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plans, life insurance and a flexible spending account for health care and/or dependent care. Role Summary:Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve We are seeking a Principal/Associate Director, Statistician to join the Biostatistics Group. This position will report to the Senior Director, Biometrics and be located in the Waltham, MA office. Key Responsibilities: ? Serve as a lead statistician and manage statistical efforts for multiple clinical studies and/or a clinical program ? Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles ? Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings ? Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses ? Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents ? Work with statistical programmers or CROs to generate tables, figures and listings ? Perform ad hoc and exploratory statistical analyses as needed ? Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results ? Support regulatory submissions as needed; provide response to regulatory requests independently ? Support the preparation of publications, including manuscripts, posters and oral presentations ? Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs Required Qualifications:? Principal Statistician: PhD in statistics or a related field with at least 4 years of relevant clinical trial experience or MS in statistics or equivalent with at least 6 years of relevant clinical trial experience ? Associate Director, Statistician: PhD in statistics or a related field with at least 6 years of relevant clinical trial experience or MS in statistics or equivalent with at least 8 years of relevant clinical trial experience ? Knowledge of statistical methods for clinical trials ? In-depth Knowledge of FDA, EMA and ICH regulations and guidelines ? Proficient in statistical programming (SAS is required) ? Experience with trial design software (e.g., EAST or nQuery) ? Good communication skills and ability to work with cross-functional study teams ? Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities ? Good analytical and problem-solving skills ? Positive and collaborative attitude Preferred Qualifications: ? Experience with NDAs/BLAs, MAAs and other regulatory submissions is a plus ? Proficient in running simulations using either SAS or R Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary: Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve We are seeking a seasoned Clinical Data Manager who can lead and contribute to data management activities in support of Deciphera studies across all stages of clinical drug development. This position will report to the Associate Director of Data Management and will be located in the Waltham, MA office. Key Responsibilities: ? Contribute to data management activities as a lead study data manager in support of Deciphera clinical studies ? Participate in the development of all Data Management documentation including the Data Management Plan, CRF Completion Guidelines, Data Validation Specification, E-Data Reconciliation Plans, Data Review Plan, etc. ? Perform clinical data processing/management including query generation, electronic data reconciliation etc. ? Plans and oversees execution of User Acceptance Testing ? Assist in preparing clean databases, including reviewing responses to queries for appropriateness, resolve any discrepancies and modifying the database accordingly ? Ensures study compliance with SOPs and regulations ? Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders ? Ability to communicate well and represent data management effectively and diplomatically in a project team environment ? Liaise with CRO??s, EDC vendors and other third-party vendors ? Monitor timelines and ensures that clinical data management deadlines are met with quality ? Support GCP inspection readiness ? Performs other duties as assigned Required Qualifications: ? Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Pharmaceutical Industry or CRO ? Demonstrated experience with Electronic Data Capture (EDC) ? Knowledge of clinical research, medical terminology/disease processes and clinical practice ? Strong interpersonal, communication, organization, critical thinking, and problem-solving skills; able to adapt to internal/external deadlines and oversee vendors ? Experience working with MSOffice Suite (Excel, Word, PowerPoint) Preferred Qualifications: ? Experience with the implementation of industry standards (CDISC, CDASH, and SDTM) ? Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management ? Highly motivated; detail and process oriented; welcomes challenge and responsibility; team-player and can achieve results in a fast paced and changing environment Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary: Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve We are seeking a Manager/Senior Manager, Strategic Outsourcing to support all clinical outsourcing activities as well as other corporate sourcing activities as requested. The position will work cross-functionally with internal stakeholders such as Data Management, Biostatistics, Translational Medicine, Legal, and Finance. General responsibilities include working with teams to properly assess outsourcing opportunities and provide contractual negotiation support, performance monitoring and follow-up. The successful candidate must be hands-on and comfortable developing procedures, templates, and relationships and work with the Director to contribute to growth and future state of the organization. This position will report to the Director, Strategic Outsourcing and be located in the Waltham, MA office. Key Responsibilities: ? Support the outsourcing process and activities for Clinical Development. ? Manage contracting activities including the preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments while minimizing risk across a broad scope of clinical / therapeutic outsourcing services. ? Assist and/or manage the identification and selection process of clinical vendors such as CROs, central labs, IRT, Imaging, ePRO, Safety vendors, etc. ? Work closely with Clinical Business Operations and Finance to assure the assumptions for studies are aligned between finance and clinical forecasting. ? Meet with clinical trial managers, functional managers, Legal, and QA as needed to ensure vendors are meeting expectations and review progress against contract. ? Create and maintain outsourcing/vendor oversight standards and templates. ? Contribute to the development of an established preferred clinical vendor list. Required Qualifications: ? Bachelor??s degree with at least five to eight years of experience with a focus on developing and overseeing clinical budgets, and contracts with clinical outsourcing vendors in the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) ? At least four years of direct clinical trial and/or vendor oversight experience required; experience negotiating, administering, extending, terminating, and re-negotiating contracts ? Excellent interpersonal, organizational and multi-tasking skills. ? Ability to interface with vendors, collaborators, all internal departments and all levels of management ? Understanding of Clinical/Drug Development; familiar with Regulatory Guidelines including ICH GCP. ? Previous experience working with clinical operations and finance is preferred. Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary: Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture and opportunity for personal and professional growth based on these key principles: ? providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals ? a diverse and multi-disciplinary workforce ? dedicated and talented people who are passionate about achieving excellence in all they do ? a work environment that allows you to balance your priorities ? above all else, a commitment to the patients we serve We are seeking a Translational Medicine Operations Specialist to work across all programs, partnering primarily with colleagues in Clinical Development, Clinical Operations and Program Management to ensure robust clinical sample and vendor management is in compliance with protocols, regulatory guidance and project timelines. The TM Operation Specialist will be responsible and accountable for managing/overseeing the entire sample and vendor management process for assigned projects from acquisition through analysis and final disposition. This position will report to the Head of Translational Medicine and be located in the Waltham, MA office. Key Responsibilities: ? Work closely with Clinical Operations and Translational Medicine to coordinate and manage the sample collection for on-going and planned clinical trials that have translational medicine objectives in their design. ? Manage kit preparation, sample collection procedures, shipping requirements, analytical data collection/reporting. ? Ensure robust chain-of-custody for clinical trial specimens. ? Manage contracts (material transfer agreements) with academic institutions and/or commercial partners that provide bio-specimens as part of collaborative or service provider agreements. ? Ensure/verify that collaborators have appropriate documentation, process and procedures in place to ensure samples are collected according to ethical and legal standards (both prospective or retrospective sampling) ? Manage budget negotiations ? Provide clinical trial budget forecasts that relate to all aspects of sample management (acquisition, transport, storage, analysis) ? Develop knowledge/understanding of regional bio-specimen applicable regulations to help facilitate protocol approvals by global ethics committees. Required Qualifications: ? BS or MS degree in science with a strong track record in bio-pharma industry working on clinical development projects and in cross-functional team environment ? 3-5+ years of experience in industry ? Must have CRO/Vendor management experience ? Experience with contract and budget development, negotiation, and management; vendor management; and data and sample management ? Knowledge of GCPs for global compliance ? Protocol development experience a plus ? Interpersonal skills required to communicate effectively with collaborators and cross functional teams. ? Highly motivated and enjoys working in a fast-paced, dynamic environment. ? Excellent writing skills. ? Strong project management skills. ? Strong organizational skills, ability to prioritize and handle competing priorities. ? Positive, flexible self-starter who thrives under pressure. ? Excellent judgement and problem-solving skills. Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary: Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a ??switched off?? or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We offer an outstanding culture focused on: ? Providing a collaborative and energized work environment ? A diverse and multi-disciplinary workforce ? Dedicated and talented people who are passionate about achieving excellence in all they do ? A commitment to the patients we serve We are seeking a Recruiting Coordinator to be an integral part of the Human Resources team and collaborate with people from all departments and functions. In this highly visible role you will support candidates and hiring managers through all stages of recruiting and on-boarding. This position will report to the Director, Talent Acquisition and Senior HR Business Partner and be located in the Waltham, MA office. Key Responsibilities: Coordinate and schedule candidate interviews Manage job postings and applicant tracking system Candidate offer letters Greet and provide general support to guests and candidates Manage the new hire onboarding process Support Talent Acquisition team Partner with the HR team on employee communications, employer branding, employee referral and other promotional programs Required Qualifications: Bachelor??s degree with 1 + years of relevant work experience Energetic, can do attitude Great communication and writing skills Excellent customer service skills and attention to detail Strong MS office skills including ?? Outlook, PowerPoint and Excel Experience with Applicant Tracking Systems a plus Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a ??switched off?? or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We are seeking a Senior Director, Drug Substance MS&T, who will have overall responsibility for leading and managing late-stage development and commercial manufacturing activities for drug substance, DS intermediates and starting materials. The scope of the role encompasses process development, scale-up, and characterization/design space mapping, process performance qualification (PPQ), routine commercial manufacturing, technical transfer and process/operational improvement initiatives. Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for CDMO selection and oversight, and the development of strong and enduring business partnerships. The successful candidate will also assume a key leadership role in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs, and will support strategic partnerships relating to potential in-licensing and/or out-licensing opportunities and external collaboration agreements. The successful candidate will have significant experience in CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercial launch. S/he will possess strong leadership, management and communication skills, ensuring that external business partners understand and respect program goals, objectives, priorities, and timelines. This position will report to the Chief Technical Officer and be located in the Waltham, MA office. Key Responsibilities: ? Lead and manage cross-functional teams engaged in external cGMP manufacturing of drug substance, DS intermediates, and starting materials. ? Lead and manage process transfers and associated site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives. ? Monitor, track and trend process performance. Develop and implement data analytics to support investigations and provide historical baseline for future operational and process-related improvements. ? Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events. ? Work closely with internal Quality Assurance, Regulatory CMC, Supply Chain and Commercial functions and external manufacturing operations to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones. ? Lead the selection of drug substance CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish KPIs to monitor site technical, quality and business performance. ? Develop and maintain strong relationships with CDMO business partners and participate in quarterly Joint Steering Committees across the supply chain. ? Review/approve technical reports, controlled GMP documents and CMC content for Module 3 CTDs. ? Develop and manage scope, milestones, interdependencies, budgets and timelines associated with drug substance program deliverables. ? Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address CMC and supply chain risk. ? Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of drug substance program deliverables with overall program strategy. ? Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities. Required Qualifications: ? A B.S./M.S. degree in chemistry, chemical engineering or related life sciences discipline with at least 15 years of experience in small-molecule pharmaceutical product development and commercialization. ? Track record of success in leading and managing small-molecule drug substance MS&T programs in a 100% outsourced environment. ? Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills. ? Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints. ? Strong decision-making skills and ability to influence internal and external stakeholders. ? Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration. Extensive experience in working with regulatory authorities. Track record of authoring and defending Module 3 CTD content through regulatory approval and commercialization. ? Ability to articulate complex issues and ideas with clarity to enable understanding and decision making. ? Ability to work successfully in a team/matrix environment and independently, as required. ? Ability to influence cross-functionally to enable improvements and enhance performance across CMC development, MS&T and supply chain functions. ? Pragmatic, solution-oriented thinker who possesses a ??can do? and ?whatever it takes? attitude, coupled with excellent organizational and communication skills. ? Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view. ? Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution. ? Ability to travel (20%) to CDMO domestic and international sites. ? Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools). Preferred Qualifications: ? Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred. ? A Ph.D. degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired. Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care. Role Summary: Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a ??switched off?? or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We are seeking a Director, Regulatory CMC to provide Regulatory CMC leadership across multiple development programs. This position will report to the Vice President Regulatory Affairs & Quality and be located in the Waltham, MA office. Key Responsibilities: ? Develop and implement CMC regulatory strategies for investigational products ? Work closely with Regulatory, Manufacturing, and Quality to support investigational product activities and maintenance of submissions ? Act as point of contact with FDA for CMC regulatory matters for investigational products. ? Lead cross-functional resources to compose high quality, global CMC investigational and marketing dossiers ? Ensure regulatory documents are comprehensive, complete and accurate ? Maintains dialogue with regulatory agencies/personn
Associated topics: administrative officer, administrative staff, assistant, asso, associate, chief operations officer, document, facilities, staff, support

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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