VP, Global Head of Drug Safety & Pharmacovigilance | Clinical-Stage Biotech | Boston/Cambridge, MA Area (Hybrid)

VP, Global Head of Drug Safety & PharmacovigilanceClinical-Stage Biotech | Boston/Cambridge, MA Area (Hybrid)Title: Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)Reports to: Chief Medical OfficerTeam: Builds and leads the global DS & PV function (operations, compliance, and safety medical), with FSP and consultant partnersLocation: Boston/Cambridge, MA area (hybrid) preferred. Other US and international locations considered for the right candidate.Leadership: Member of the company’s senior leadership teamABOUT OUR CLIENTOur client is a well-funded, clinical-stage biotechnology company developing novel biologic therapies for serious diseases with high unmet medical need. It has multiple programs in the clinic, with its lead program advancing into late-stage, pivotal development.The company has US and international operations and a strong financial position. It is building the leadership team that will take it from clinical-stage to a global, late-stage, and pre-commercial organization.THE OPPORTUNITYAs our client’s lead program moves into pivotal development, with more programs following and global filings on the horizon, safety leadership has become a strategic priority. The company is appointing a Global Head of DS & PV to own the function and build it for the long term.Reporting to the Chief Medical Officer and serving on the senior leadership team, the Global Head of DS & PV will set safety strategy across the portfolio. You will build a fit-for-purpose safety system that scales from late-stage development through registration and commercialization, and grow a team designed to provide dedicated safety leadership for each program.KEY RESPONSIBILITIESSafety Strategy & Medical OversightLead DS & PV and risk management activities for all programs, from first-in-human through late-stage development and registration.Provide safety medical oversight of surveillance and benefit-risk assessment, including medical review of ICSRs, signal detection and management, aggregate safety analyses, and risk mitigation strategies.Lead the company’s safety governance and, where applicable, support Data Safety Monitoring Committees.Regulatory & SubmissionsServe as SME author, reviewer, and approver for safety content in regulatory submissions (DSUR, BLA/NDA, MAA), clinical study documents, labeling, Company Core Safety Information, and Risk Management Plans.Represent the company with health authorities, including presenting safety data and leading responses to safety questions, audits, and inspections.Ensure compliance with global PV regulations (FDA, EMA/EU GVP, ICH) as the company prepares for filings in the US, EU, and additional regions.Building the FunctionBuild the global DS & PV department, including operations, compliance, and medical functions, with dedicated safety leadership for each program as the portfolio grows.Establish scalable infrastructure: safety database and vendor strategy, SOPs, PV agreements, inspection readiness, and preparation for post-marketing obligations.Select and oversee external PV resources, including safety FSPs and consultants, and manage the DS & PV budget.Mentor and develop a high-performing team with a strong culture of safety, compliance, and operational excellence.Cross-Functional LeadershipContribute to overall company strategy as a member of the senior leadership team.Partner with Clinical Development, Clinical Operations, Medical Affairs, Regulatory, Quality, and Biometrics to build safety thinking into program strategy early.QUALIFICATIONS & EXPERIENCERequiredMD with 12+ years of experience in drug safety, pharmacovigilance, and risk management in the biopharma industry.Prior experience as Head of DS & PV, including building and leading safety teams across operational, compliance, and medical functions.Late-stage clinical development experience and direct involvement in BLA/NDA and/or MAA submissions.Deep expertise in global PV regulations, safety surveillance, signal management, and risk management.Track record of health authority interactions, inspections, and audits.Excellent written, verbal, and presentation skills, with the ability to influence across functions and with external partners.PreferredExperience with biologics.Rare disease or specialty therapeutic area experience.Experience taking a safety organization from clinical-stage through approval and into commercial readiness.Global PV experience across US and EU requirements, plus exposure to other ex-US markets.LEADERSHIP ATTRIBUTESPatient-centered: treats safety as a direct expression of the company’s commitment to patients.Hands-on builder: strategic enough to design the function and practical enough to run it while it is being built.Curious and rigorous: questions data, anticipates risk, and holds high standards of scientific and ethical integrity.Collaborative partner: brings safety perspective early and constructively, across teams and time zones.WHY THIS OPPORTUNITYA chance to shape and build a global safety function the right way.A seat on the senior leadership team at a company moving toward global registration.Meaningful work for patients with serious diseases and limited treatment options.A well-capitalized company with the resources to invest in its leadership team.CONTACT:Recruiting Teamsspinelli@cornerstonesg.com – P 973-656-0220Cornerstone Search Group, LLC1200 Morris Tpke, Suite 3005 | Short Hills, New Jersey (USA)www.cornerstonesg.com