Executive Director, Medical Safety Strategy and Benefit Risk Management

Company: Insmed Incorporated
Location: Bridgewater
Posted on: July 20, 2025

Job Description:

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row. A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational and marketed products while spearheading the integration of new technology and processes to enhance patient safety and benefit risk management. The ED will provide day-to-day leadership and guidance to the Medical Safety Strategy and Benefit-Risk Management group within DSPV to ensure timely delivery of high priority tasks in accordance with all relevant company and regulatory policies and procedures. This role also oversees global safety and risk management activities for Insmed's portfolio with a focus on proactive signal detection, signal management, and benefit-risk evaluations ensuring strategic alignment throughout the product's lifecycle. This position reports to the VP, DSPV and may serve as delegate during his absence. Responsibilities Responsibilities and job scope: Lead the DSPV Medical Safety Strategy and Benefit-Risk Management group providing strategic direction, oversight and leadership across all activities including the ongoing and cross functional assessment of benefit risk profiles for development compounds and marketed products. Provide high level strategic consultation and subject matter expertise on decisions with significant safety impact including safety signal detection, evaluation, validation, escalation, and communication for Insmed's portfolio. Ensure effective monitoring and proactive management of medical safety deliverables. Provide medical review, scientific content input, and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. Provide strategic leadership in the advancement of global medical safety operations in alignment with strategic safety objectives and operational excellence functions. Provide medical expert safety review input into all critical documents for clinical development of products including protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, and CTAs ensuring safety content is clear, accurate, and compliant. Lead the analysis and interpretation of safety data for inclusion in regulatory submissions and marketing applications in partnership with Clinical Development and other relevant functions. This includes NDA/MAA safety sections, reference safety information (i.e, CCDS), PSUR/PBRER, DSUR, as well as scientific publications, abstracts, and presentation materials. Lead the development and ongoing review of Risk Management Plans (RMPs), Risk-Evaluation and Mitigation Strategies (REMS), and other PV tools that support Regulatory Compliance and patient safety. Responsible for the preparation of responses to safety-related inquiries from regulatory authorities; provide guidance and final review of submissions authored by other Medical Safety Leads. Develop, track, and report on critical metrics and quality indicators, identifying trends and implementing corrective and preventative actions. Oversee medical safety and pharmacovigilance activities conducted with external partners including contract research organizations (CROs) and vendors. Assist with the selection, oversight and monitoring of these partners to ensure compliance with company policies, regulatory requirements, and timely completion of safety-related deliverables. Ensure the Medical Safety Strategy and Benefit-Risk Management group maintains a constant state of audit and inspection readiness. Support in planning, prioritizing, and managing budgets for the DSPV function to align with corporate objectives and changing business needs. Establish and track safety objectives and manage team performance through regular feedback, development planning, and performance evaluations to drive accountability and excellence. Participate in building the talent pipeline for key roles within the department. Contribute to succession planning and team development by identifying high-potential individuals and supporting the growth of future leaders. Participate in cross-functional initiatives and enterprise-wide projects to support DSPV objectives and promote a culture of safety, compliance, and continuous improvement. Perform additional responsibilities and duties as needed to support business objectives. Requirements: Medical degree (MD or equivalent) required; specialty board certification is highly desirable. Advanced training in Pharmaceutical Medicine, Epidemiology, or Public Health (e.g., MPH, MSc, PhD or equivalent experience) strongly preferred. 4 years of postdoctoral clinical experience required in hospital or academic setting. 10 years of experience in drug development within a biotech or pharmaceutical company, including a minimum of 8 years in a safety-related position. Ability to influence and drive organizational changes, especially in the context of building new capabilities, streamlining safety processes, or implementing innovative technologies. Comfortable operating in a global role with cross-cultural awareness and the ability to lead and collaborate with teams across multiple time zones and regions. Significant experience in Global Pharmacovigilance with proven understanding of global PV regulations, GVP Requirements, and relevant ICH guidelines. Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information. Experience in leading roles in clinical or safety through complete submission process. Strong leadership capabilities with a track record of coaching, mentoring, and fostering high performing collaborative teamwork. Skilled in presenting clinical and safety data to global health authorities with experience in regulatory meetings and safety related discussions. LI-MM1 LI-Remote Salary Range 319000-382600 Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here . Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Keywords: Insmed Incorporated, Lower Merion , Executive Director, Medical Safety Strategy and Benefit Risk Management, Science, Research & Development , Bridgewater, Pennsylvania