General Scope and Summary
SAGE Therapeutics is searching for an experienced Sr. Medical Director/Medical Director of Drug Safety and Pharmacovigilance (DS&PV) that is a creative, resourceful and integrative thinker. The Sr. Medical Director/Medical Director serves as the global lead for the pharmacovigilance and risk management of assigned investigational and/or marketed products. This is a highly visible role that will interface across all levels of management and functional areas and is responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. . Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.
Roles and Responsibilities
- Lead product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
- Maintain knowledge of Sage therapeutic area diseases and assigned product(s) safety and efficacy profile
- Ensure that routine signaling activities assessment and investigation are completed and documented per SOPs
- Respond to safety-related queries from regulatory authorities, IRBs/ECs
- Lead product benefit-risk assessment discussions at Safety Governance Committee
- Includes needed actions to update Reference Safety Information or risk minimization actions
- Lead DS&PV representation for clinical development of the assigned product(s) including:
- Clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data
- Safety content of IB, Reference Safety Information, ICF
- Regulatory filings (ISS, Benefit-Risk, RMP/REMS as required)
- Responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR)
- Conduct medical review of individual case safety reports (ICSRs)
- Includes appropriate follow-up requests and accuracy and timeliness of expedited reports
- Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and compliance with global regulations
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- MD, MD PhD or MD MPH required
- Minimum of 3-7 years’ experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry
- Sound clinical acumen and decision making
- A proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency.
- Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
- Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing
- Demonstrated leadership and collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.
- Level will be commensurate upon experience and qualifications.
- Excellent oral and written communication skills
- Prior experience contributing to the development (process improvement, training, etc.) of a drug safety would be desirable
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
- Excitement about the vision and mission of Sage