Vice President, Clinical Development - Gene Therapy at Insmed Incorporated in Bridgewater, New Jersey

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 Vice President, Clinical Development will be a hands-on leader with the expertise to drive strategic clinical initiatives and clinical programs for Insmed's gene therapy portfolio. The role demands strong leadership to advance existing clinical plans while also serving as the strategic clinical leader. This role will co-lead cross functional program level team(s). In addition to these responsibilities, the Vice President will oversee the preparation of critical clinical documentation (e.g., protocols, study reports, IND & NDA submissions) for clinical studies working with the respective clinicians, clinical research scientists, and members of the Biometrics and Development Operations organizations. This role will be accountable for the medical monitoring across all studies working with and leading the respective clinicians and clinical research scientists. A key part of the role will also involve developing and managing relationships with Key Opinion Leaders (KOLs) within relevant therapeutic areas. This position will report to the Chief Development Officer.



Responsibilities

• Provide medical/scientific expertise by working closely with Clinical Scientists and Clinical Operations teams throughout the lifecycle of gene therapy clinical studies, from pre-study planning to post-study analysis. Proactively identify and resolve study design issues that may arise during gene therapy trials.


• Co-lead a global study team, alongside Program Management, to advance gene therapy assets, particularly through Phase II and beyond. Collaborate effectively with cross-functional teams such as Data Management, Biostatistics, and Regulatory Affairs, to ensure seamless execution of the gene therapy development plan.


• Offer medical expertise across functions, including collaborating with Drug Safety and Pharmacovigilance to monitor safety signals and manage gene therapy-related adverse events.


• Support the preparation and presentation of scientific materials, such as abstracts, manuscripts, and conference presentations, as well as Advisory Board materials relevant to gene therapy programs.


• Present protocols and other materials at Investigator Meetings, training sessions, and other internal or external forums as needed, particularly related to gene therapy studies.


• Provide medical guidance during data reviews, interim analyses, and blinded data assessments for gene therapy trials.


• Review and provide feedback on statistical analyses and collaborate with Data Management teams on the development of eCRFs, edit checks, coding, and other data processes necessary for gene therapy studies.


• Stay current on scientific and medical advancements in gene therapy and maintain relationships with external experts. Represent Insmed in external groups and professional organizations focused on gene therapy.


• Contribute to the strategic development of both early and late-stage gene therapy clinical programs, ensuring alignment with corporate objectives and regulatory requirements.


• Participate in due diligence activities as needed, contributing medical and scientific expertise during the evaluation of investigational agents and/or platforms.

Qualifications/Requirements:

• MD required, preferably with Board certification, with s pecialization in rare diseases, neurology, or neuromuscular diseases is strongly preferred.


• 12+ years clinical development experience in the pharmaceutical or biotech industry with direct experience in Phase 2-4 clinical development, particularly in complex or rare diseases.


• Deep experience within the gene therapy realm to include knowledge of multiple therapeutic areas.


• Demonstrated success in building and maintaining strong relationships with Key Opinion Leaders (KOLs) and external experts to advance gene therapy assets.


• Extensive experience developing and submitting complex NDAs and BLAs is required.


• Previous direct people management experience is paramount for this role.


• Strong working knowledge of Good Clinical Practice (GCP), scientific and clinical methodology, clinical trial design, project management, and the regulatory landscape specific to gene therapy or rare disease clinical studies.


• Demonstrated leadership presence, with the ability to work effectively with clinical, regulatory, and scientific leaders both within Insmed and externally.


• A problem-solver and collaborative team player who actively encourages and values the contributions of others.


• Strong patient focus with a passion for advancing medical treatments through the development of innovative gene therapies. Commitment to making a meaningful impact on patient care.


• Excellent communication skills, with an emphasis on transparency, clarity, and precision. Highly organized with strong attention to detail, accuracy, and the ability to convey complex scientific concepts clearly.


• Demonstrated ability to work effectively both independently and as part of a team. Strong internal-facing leadership and interpersonal skills with a high degree of professionalism, maturity, and the ability to navigate complex gene therapy development environments.


• Strong analytical skills with the ability to interpret complex data sets and make informed decisions.


• Experience in vendor management is a plus, particularly in the context of outsourced gene therapy or rare disease development services and collaborations.


• Willingness to travel up to 35%, both domestically and internationally, with potential periods requiring up to 50% or more travel, particularly for gene therapy trial oversight and KOL engagements.


• Must exemplify Insmed's values of Collaboration, Accountability, Passion, Respect, and Integrity.

#LI-MM1
#LI-Hybrid



Salary Range



387000-451000



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/Affirmative Action employer. 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. Apply Now