This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera is leveraging its proprietary switch‑control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch‑control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.
The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability—empowering individuals to challenge the unknown together.
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.
Job Description
We are seeking a Senior Medical Director, Pharmacovigilance to support global pharmacovigilance for marketed and/or investigational products. In this role, you will be responsible for overseeing activities such as medical review of cases, signal management, aggregate reports, risk management, ad hoc safety query responses, literature surveillance, safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (protocols, IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable) while serving as a key medical expert in cross‑functional teams and regulatory interactions.
Key Responsibilities
Lead benefit risk for the assigned products
Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned products throughout the life cycle of the compound.
Provides pharmacovigilance expertise to oversee and lead decision making basedrisk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
Oversee team contributions to safety‑critical documentation such as regulatory submissions (INDs, NDAs, MAAs)
Attend/lead Safety Committee meeting to support key decision‑making, drive conclusions and develop next steps
Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit‑risk assessments
Participate in development and maintenance of risk management plans (RMPs) and REMS as applicable.
Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports as needed
Contribute to preparation of relevant regulatory documents and responses to regulatory agencies, Institutional Review Board (IRB), Investigational Site and Medical Information queries
Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
Lead the medical review activities for IC
Perform medical review and assessment of adverse event reports for marketed and investigational products, including review of coding, consistency in assessment, case narrative, company assessment and case documentation
Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
Adhering to documented procedures and company/vendor timelines for IC
Attend Kick-Off meetings, weekly case medical review, study team meetings, and vendor meetings, and other meetings as needed or requested.
Lead the safety related sections of the study documents
Ensure appropriate safety content of the study documents such as study protocol (s), Investigator Sponsored Research (ISR), Investigator Brochure /Reference Safety Information, Informed Consent Form risk language
Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion criteria, and issues of patient safety and/or eligibility, IRB responses for safety related queries
Present and lead safety data presentation in Data Monitoring Committee (DMC) and participate in data review meetings
Qualifications
Other duties and responsibilities as assigned
MD from an accredited institution (board certified preferred; board eligible or OUS equivalent)
10 + years of pharmacovigilance / drug safety experience, leadership role within a pharmaceutical, biotechnology, or CRO environment
Strong scientific/clinical and analytical background; able to assess data and interpret safety/medical implications
Proficient in understanding and evaluating technical, scientific, and medical information; experienced with clinical data collection, assessment, and analysis
Proven ability to work independently or collaboratively within teams (Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory) and with external partners
Solid understanding of global drug development and pharmacovigilance guidelines/regulations
Highly detail-oriented, organized, and capable of managing multiple tasks to meet deadlines
Strong teamwork, collaboration, and effective verbal and written communication skills
Preferred Capabilities
Demonstrated expertise in a broad range of therapeutic areas, showcasing adaptability and depth of medical knowledge.
Proven ability to excel in dynamic, high-growth international settings, effectively navigating cross-cultural and multidisciplinary teams.
Advanced skills in utilizing industry-standard pharmacovigilance systems (such as Argus and ARISg), the Microsoft Office, and medical coding dictionaries, with the added capability to implement emerging digital tools, optimize workflow automation, and analyze large datasets for actionable safety insights.
Additional capabilities include strong project management skills, the ability to lead global process optimization initiatives, and experience in designing and delivering training programs to enhance team performance in pharmacovigilance operations.
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $292,000 - $402,600. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long‑term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
Benefits
Competitive salary and annual bonus.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
Generous parental leave and family planning benefits.
Outstanding culture and opportunities for personal and professional growth.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non‑discriminatory basis.
#J-18808-Ljbffr
Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.