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.

 

	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.

 

The Senior Director (SD) will serve as a key leader responsible for driving innovative solutions, advancing technology, and supporting business and financial activities across DSPV. This role will lead the identification and implementation of innovative tools, digital systems, and process enhancements and will be instrumental in investigating emerging methodologies, real-world evidence, and technology solutions to enhance Insmed PV solutions. This position will report to the VP, Drug Safety and Pharmacovigilance

Innovation and Technology

• Lead DSPV innovation and technology projects ensuring alignment with corporate goals and regulatory expectations.
• Collaborate with Insmed DSPV and external stakeholders on project strategy, planning and execution.  
• Develop, implement, and enhance tools and methodologies for signal detection, benefit risk evaluation, and risk mitigation throughout product lifecycle.
• Innovate and evolve models and tools for evaluating benefit-risk throughout the product lifecycle in accordance with Insmed DSPV SOPs in this area.
• Drive digital innovation projects including AI, RWE, and any other advanced technologies in pharmacovigilance.
• Support and promote innovation in operational processes and PV technology.
• Lead the development of safety strategy tools to support early identification and mitigation of emerging risks.
• Lead and support enhancement and development of patient exposure data tools in Insmed.
• Collaborate with DSPV stakeholders and other Insmed functions to contextualize and enhance the interpretation of safety data from both clinical and post-marketing sources.
• Conduct or support gap analysis of PV systems focusing on tools and technology.
• Manage deployment of new safety systems and platforms to improve signal detection and risk management.

Business Solutions

• Oversee DSPV business solutions, including budgeting, financial planning, and resource management.
• Lead all financial business contracts and management of these related to the PV and PV related vendors.
• Develop financial forecasts, long-term plans, and scenario analysis to guide decision making.
• Interface with regulatory authorities during safety communications and inspections for areas of responsibility.
• Monitor spending and provide regular budget & contract variance analyses to DSPV Leadership.
• Prepare financial models and scenario analyses, implementing cost-saving initiatives.
• Collaborate closely with finance and accounting teams to ensure accurate financial reporting and resolving discrepancies.
• Provide strategic financial recommendations to support business planning and key initiatives.
• Manage the DSPV department’s annual budget to align with corporate priorities and goals.
• Partner across different departments to support internal projects and cross functional initiatives.
• Stay current with evolving global regulatory requirements to ensure compliance and scientific integrity.

Requirements:

• Post-graduate degree in Medical or Scientific discipline such Pharmaceutical Medicine, Doctorate in Science; Master of Public Health in Epidemiology (or equivalent) is required.  If MD or DO (US or Internationally trained), specialty training and/or Board Certification desirable.
• 10+ years in drug development in a biotech or pharmaceutical company, including a minimum of 8 years in a safety-related position.
• Experience in Risk Management and Applied Epidemiology, Signaling and Clinical Safety management preferred.
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
• Ability to review and/or prepare scientific or regulatory documents from large volumes of scientific information. Strong skills in the management of safety information originating from both clinical development and post-marketing sources.
• Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines is strongly desired.
• Experience in presenting clinical or safety data to major health authorities.
• Working knowledge of industry standard pharmacovigilance databases (e.g. ARGUS or ARISg) and MedDRA and proficiency in performing data mining activities for analysis of safety data.
• Strong Leadership skills and excellent communication skills with individuals at all levels (administrative to key thought leaders) including coaching, motivating, directing, and fostering teamwork.
• Proficiency in using data analysis tools and software; implement AI and other technological advancements and their applications in safety management.
• Highly proficient in computer skills (Microsoft Word, Excel, PowerPoint, Outlook, Adobe Acrobat).

#LI-MM1
#LI-Remote

215000-301000

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.

 

 

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.