Senior Medical Director, Drug Safety and Pharmacovigilance

General Scope and Summary

SAGE Therapeutics is searching for an experienced Senior Medical Director of Drug Safety and Pharmacovigilance (DSPV) that is a creative, resourceful, and integrative thinker. The Senior 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 developing the safety strategy and the identification of safety signals, signal investigation, and the proactive management of the benefit-risk profile for assigned products. Additionally, the Senior Medical Director will collaborate with the Executive Medical Director, DSPV to develop and mentor team members, including other Safety physicians.Effective communication skills are key, as this role provides an excellent opportunity for close collaboration with colleagues from other functions, including but not limited to Clinical Development, Clinical Operations, Regulatory Affairs, Nonclinical Development, Data Science, and Medical Affairs.

Roles and Responsibilities

• Lead product safety surveillance strategy and activities for assigned product(s) during all phases of the product life-cycle.

  • Represent DSPV on the SAGE product program team(s).

  • 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 the Safety Surveillance Team (SST) and presentations to the Safety Review Committee (SRC).

  • Perform needed actions to update Reference Safety Information or risk minimization actions.

• Lead DSPV 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, and ICF.

  • Regulatory filings (ISS, Benefit-Risk, and RMP/REMS as required).

• Complete medical safety sections of aggregate safety reports (DSUR, PSUR, PADER) in collaboration with Safety Scientist(s).

• Conduct medical review of individual case safety reports (ICSRs).

  • Perform appropriate follow-up requests and ensure accuracy and timeliness of expedited reports.

• Assist in the successful implementation, execution, and maintenance of safety processes and systems that conform to the companys 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.Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.Must have a 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.

Basic Qualifications

• MD, MD PhD, or MD MPH.

• 10+ years of relevant experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry.

Preferred Qualifications

• Extensive early- to late-stage safety experience.

• NDA/MAA filing experience.

• People management experience, including safety physicians.

• 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, 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.

• Excellent oral and written communication skills.

• Prior experience contributing to the development (process improvement, training, etc.) of a drug safety department.

• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Companys annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.