Medical Director, Pharmacovigilance

Company Description

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom.  We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.  

See here for more details on our portfolio.

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here. 

Job Description

We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.

The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.

The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.

What You’ll Do:

• Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.
• Provides pharmacovigilance expertise to oversee and lead decision making based on  risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
• Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
• Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
• Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility
• Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and/or Case Report Forms (CRFs)
• Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment
• Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative
• Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested
• Support inspections and audits, act as a subject matter expert for the assigned program (s)
• Provide training on product and medical review to vendor/ team members as needed
• Completes tasks on time or notifies appropriate person with an alternate plan.
• Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
• 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 and REMS as applicable.
• Key member on the Prod