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.

We are seeking a motivated, skilled, and operationally minded physician/executive to play a pivotal role in the ongoing development of several gene-therapy clinical programs and to coordinate the growth and collaboration of multiple groups comprising the clinical development organization. In this newly created and highly visible role, the Vice President Clinical Development, Gene Therapy will hold a leadership role to further our development efforts involving transformative gene-based therapies for rare and life-threatening Neuromuscular and cardiovascular disorders. The candidate will have demonstrated expertise in leadership of multidisciplinary teams focused on clinical investigation of complex, severe disorders in a biotechnology or pharmaceutical setting.

The position will report to the Chief Scientific Officer and will involve intense collaboration within the organization and with external academic and industry partners to ensure optimal study conduct, reporting and adherence to GCP guidelines and other relevant health authority regulations.

Must be local (San Diego, CA, west coast) or willing to travel to SD on a regular basis or willing to relocate. Travel could be up to 20% if local to SD or 40-50% if not local.

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Responsible for design and execution of clinical studies
• Lead or oversee development of study related documents including protocols and study reports
• Provide strategic input into the research direction of programs by interaction with external academic collaborators and internal leadership teams.
• Strategic evaluation of diseases of interest to Insmed and integration in the development vision and planning
• Establish, grow, and maintain key relationships with global leaders in gene therapy, and translational medicine fields
• Provide oversight to collaborative programs and maintain strong relationships with investigators and key opinion leaders in the field with national and international exposure.
• Lead and provide strategic input to ensure optimized development planning in close collaboration with other senior functional leads
• Lead and oversee the clinical content and contribute to the overall strategy in all regulatory submissions and interactions
• Mentor Medical Directors and Clinical Development Scientists, and promote research of innovative clinical trial methods, teamwork and quality
• Participate in establishment of efficient processes, standards and SOPs
• Consult with and support other functions including Research and Preclinical Development
• Provide a clinical perspective to the overall business strategy, incorporating commercial and competitive viewpoints, and effectively communicate scientific and medical data results/information to all internal and external stakeholders

• MD or MD/PhD with at least 12 years of relevant experience who has completed training in a complex specialty, ideally with experience in gene-therapy or other complex therapeutic area.
• Pharmaceutical/biotechnology industry experience with a demonstrated track record in scientific research and clinical development
• Candidate must have demonstrated expertise in oversight of clinical studies evaluating advanced therapeutics in complex or life-threatening disorders.
• Extensive Phase 1-4 clinical development experience in an industry setting, including first-in-human and pivotal studies
• Extensive knowledge of clinical trial methodology, statistics, regulatory and compliance requirements governing clinical trials, including GCP
• Proven ability to lead by example within a collaborative, dynamic, high growth culture, championing and advancing novel concepts within cross-functional matrixed teams
• An innovative, results-oriented, solutions focus and critical thinking skills
• The motivation to build a culture of pioneering science with aspirations to develop products that will change the lives of people with serious diseases
• Extensive regulatory interactions experience
• Innovative focus and ability to champion and advance novel concepts

• Flexible approach to where and how we work
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer