Insmed is a global biopharmaceutical company dedicated to creating life-transforming therapies for patients with serious and rare diseases that have limited tre
Director, Medical Safety Lead - DSPV, Gene Therapy
Location
United States
Posted
75 days ago
Salary
$247K - $337K / year
Seniority
Lead
Job Description
Director, Medical Safety Lead - DSPV, Gene Therapy
Insmed
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’re looking for a Director, Medical Safety Lead - DSPV Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the Sr Director, DSPV Gene Therapy Safety Lead, the Director, Medical Safety Lead serves as the DSPV subject matter expert for assigned products, maintaining deep and up-to-date knowledge of the product portfolio and associated safety profiles. This role is responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products. It includes medical evaluation of individual adverse event reports, oversight of aggregate report generation and safety documentation, and collaboration on labeling updates. The position also provides expert DSPV support to both internal and external stakeholders. What You'll Do: In this role, you’ll have the opportunity to review all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds. You’ll also: - 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. - 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 DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products. - Provide input into the writing of periodic reports for assigned products; provide medical interpretation, review, and approval for required reports. - Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal. - Provide expert safety input to the clinical development program for assigned products and development compounds. - Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds. - Provide integrated safety input into all regulatory documents, thorough assessment of safety profiles for Due Diligence projects, and provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters. - Respond to inquiries from regulatory authorities on safety issues. Who You Are: You must have an MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance within a pharmaceutical industry setting across both investigational and marketed products. Additionally, you have: - Experience reviewing and preparing scientific or regulatory documents from large volumes of scientific information. - Knowledge and understanding of national & international Pharmacovigilance and regulatory guidelines. - Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. - Impeccable communication skills, both verbal and written. - Excellent organizational skills with a strong attention to detail, clarity, accuracy, and conciseness. - Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace. Nice to have (but not required): - Master of Public Health (MPH) is a plus. - 2+ years’ experience in Clinical Patient Care is strongly preferred. - Drug safety database knowledge is preferred. - Experience working on gene therapy products is a plus. - Product defense before a national or international regulatory authority a plus. Where You’ll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected. Travel Requirements This role requires occasional domestic travel (up to 20%). #LI-MM1 #LI-Remote Pay Range: $247,000.00-337,000.00 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: - A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or - An alternative selection process by emailing Privacy@insmed.com. - Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.
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Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. 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This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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Physician-Medical Oncologist
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