-
Back to Job Details
- Salary 300000
- LocationWaltham, Massachusetts
- Employment type Permanent
- Discipline
- Job descriptionSr. Medical Director/Medical Director, Global Safety Officer Location: Greater Boston Area This is a hybrid role requiring 60% in-office presence (3 days/week); not eligible for fully remote work. The Global Safety Officer (GSO) will provide strategic safety oversight for assigned investigational and/or marketed products within a neuroscience-focused portfolio. This role reports to the Head of Drug Safety and Pharmacovigilance (DSPV) and will serve as a visible leader in cross-functional forums, governance meetings, and strategic initiatives. The ideal candidate will have demonstrated success as a product safety physician, leading both clinical and post-marketing safety programs. They should bring deep expertise in safety surveillance, signaling, aggregate reporting, and benefit-risk assessment, with the ability to make high-impact safety recommendations. This is not a medical reviewer role - it requires strategic thinking, enterprise-level leadership, and confidence in presenting safety findings to internal governance bodies and external stakeholders. Key Responsibilities • Provide medical leadership within Drug Safety and Benefit-Risk Management. • Lead safety strategy across early and late-stage clinical trials and post-marketing programs. • Serve as the safety lead for assigned products, collaborating with cross-functional teams. • Advise on clinical development plans, protocol design, and safety content for IBs, ICFs, and DSMBs. • Develop and maintain Risk Management Plans and safety minimization strategies. • Author and oversee aggregate safety reports (DSURs, PSURs, PADERs) and regulatory safety content. • Lead safety surveillance, signal detection, and benefit-risk assessments. • Present safety findings and recommendations in internal safety committees and governance forums. • Respond to safety queries from regulatory authorities, ethics committees, and internal stakeholders. • Contribute safety expertise to publications, HEOR, epidemiology, and due diligence activities. • Represent DSPV in regulatory audits and inspections. Qualifications • MD or MD/PhD required (US training not mandatory). • Minimum of 4+ years (Medical Director) or 7+ years (Sr. Medical Director) in Drug Safety & Pharmacovigilance or relevant clinical roles. • Experience in both clinical development and post-marketing safety preferred. • Strong understanding of neuroscience therapeutic area is highly desirable. • Prior experience interacting with regulatory authorities and participating in inspections. • Proven ability to lead safety strategy and present in high-stakes governance settings. • Strategic thinker with excellent communication and organizational skills. • Ability to lead and collaborate in a matrixed, dynamic, and entrepreneurial environment. • Familiarity with global pharmacovigilance regulations and benefit-risk frameworks.