Reporting to the Head of Drug Safety & Pharmacovigilance (PV), the Senior Medical Director will provide hands-on and strategic leadership for Oncology PV activities associated with assigned Sumitomo Dannipon Pharma Oncology investigational products. This individual will manage the PV Medical Safety early stage group, function as a Safety Lead for products as needed, and work in a company matrix team environment interacting with several key stakeholders, including Clinical Development, Regulatory Affairs, Translational Medicine, Biostatistics, and Clinical Pharmacology.
- Provide managerial and strategic leadership within the Drug Safety & Pharmacovigilance Department for the early stage Medical Safety group.
- Represent PV cross-functionally and provide subject matter expertise at the team and larger company levels as required.
- Perform all PV and Risk Management activities as Safety Lead for assigned products.
- Complete routine PV activities of assigned programs including formation of the Reference Safety Information, aggregate safety reporting, signal detection, and literature review.
- Lead the cross-functional product safety management team, including escalation of safety issues to senior leadership, as needed.
- Create/update the safety/risk section in protocols, Investigator’s Brochures, and informed consent forms.
- Review and oversight of clinical and non-clinical safety data, and participation in dose escalation discussions for early studies.
- Provide medical safety expertise for monitoring of clinical trials and data and safety monitoring boards.
- Write and review clinical study reports and other documents developed for submission to regulatory authorities, including safety sections of NDAs.
- Guide and mentor Sumitomo Dannipon Pharma Oncology staff on PV best practices and help create SOPs and Work Instructions to underlie them.
- Other duties as assigned.
- MD (or ex-US equivalent) or PharmD
- Minimum of 6-10 years of experience in Pharmacovigilance
- Oncology PV experience strongly preferred
- Experience working with vendors strongly preferred
- Leadership experience including the supervision and mentoring of PV staff
- Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance
- Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster and nurture teamwork, and act as a facilitator to drive fulfillment of corporate strategic goals
- Strong communication skills with excellent written and spoken English.
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org
Equal Opportunity Employer
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