Senior Director, DSPV Medical Safety

At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:
We are seeking a highly experienced Senior Director, DSPV Medical Safety to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, DSPV, you'll be the medical expert for assigned products and maintain current knowledge of assigned product portfolio and safety profiles.

This individual will provide the day-to-day direction to the Medical Safety Team to ensure business needs and priority tasks are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures.

In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety surveillance, risk management, and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports and safety documents, including labeling changes.

What You'll Do:

In this role, you'll have the opportunity to lead strategic consultation and guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, interpretation and appropriate management and communication of safety information for Insmed's portfolio of products in development. You'll also:

• Be responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds.
• Deliver high quality and timely medical safety deliverables and provide content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee.
• Conduct safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information.
• Lead the Safety Review Team(s) for assigned products and development compounds and manage the ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds.
• Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Work with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Lead the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk-Evaluation and Mitigation Strategies (REMS).
• Prepare responses to inquiries from regulatory authorities on safety issues for assigned products and lead the integrated safety input into all regulatory documents where required.
• Maintain and evaluate Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, creating an action plan, and communicating metrics to appropriate teams and individuals.
• Lead all aspects of medical safety and pharmacovigilance activities conducted in partnership with external business partners or outsource to vendors and contract research organizations (CROs).

Who You Are:

You must have either an MD or DO with 8+ years of pharmaceutical industry experience within Drug Safety/Pharmacovigilance working with both investigational and marketed products. Additionally, you'll have:

• 5+ years of demonstrated experience with medical case reviews, aggregate reporting, safety surveillance, signal management, and/or risk management.
• In depth ability to review and/or prepare scientific or regulatory documents from large volumes of scientific information.
• Experience presenting drug safety topics, clinical and safety data to regulatory authorities, health authorities, or at conventions, meetings, etc.
• Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines.
• Experience in preparing clinical safety assessments and regulatory reports/submissions involving safety information.
• Experience in drug development and clinical trial methodology.
• Experience leading roles in clinical or safety through the complete submission process.
• Strong leadership skills including mentoring, motivating, directing, and fostering collaboration within cross-functional, multi-cultural teams.
• Strong negotiation and conflict management acumen, with excellent communication skills (both verbal and written).
• Ability to develop and maintain effective working relationships with subordinates, superiors, and peers.

Nice to have (but not required):

• Master of Public Health (MPH) in addition to the MD or DO.
• 2+ years of Clinical Patient Care experience strongly preferred.
• A background in providing product defense before a national or international regulatory authority is a plus.
• Experience within the rare disease arena preferred.
• Drug safety database knowledge.

Where You'll Work

This can be a fully remote role because the selected candidate should be able to perform effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Alternatively, if you live within a drivable distance of Bridgewater, NJ, you'll have the option to work remotely most of the time, but with more in-person collaboration when it matters most.

Travel Requirements

This role requires occasional domestic travel (approximately 10%).

#LI-MM1
#LI-Remote

Pay Range:
$273,000.00-372,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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 [email protected] 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.