Senior Director, Clinical Development

Insmed Incorporated

1d • Remote

About The Position

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 Senior Director, Clinical Development on the Clinical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Disease Area Head, Respiratory, you’ll play an important role in working with the team to execute global clinical development plans of a monoclonal antibody targeting SCF. Tasks include preparing clinical documents (e.g. protocol, IND, study report, NDA documents), providing medical oversight for investigational sites, doing research, and participating in and providing medical/scientific leadership to study team(s). In addition, a highly strategic view is required. This opportunity will require a focus on all the clinical aspects of the upcoming programs in ILD and asthma. Strong leadership skills are a must for this highly visible opportunity. This position will require working in a fast-paced, high energy, entrepreneurial environment.

Requirements

• You have an MD; board certified/eligible and/or specialization in Pulmonary/Immunology is a plus, along with a minimum of 6+ years of clinical development experience in the pharmaceutical / biotech Industry.
• Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.
• A global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.
• Must have excellent communication skills (verbal and written).

Nice To Haves

• Previous experience conducting clinical trials in Respiratory is a plus

Responsibilities

• Provide medical / scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies, before during and after conduct of studies, and identify / resolve issues related to study design that arise during study.
• Provide medical expertise where needed.
• Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.
• Provide program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs.
• Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.
• Manage production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of queries to address information gaps in CIOMS of such deaths. Review of SUSARs and contact with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each individual case.
• Keep up to date on scientific and medical progress in the area of development and actively develop and maintain relationships with outside experts. May serve as a liaison by representing the company in outside groups.
• Contribute to the strategic development of early and late-stage clinical programs.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree