Head of Clinical Development
About The Position
The Head of Clinical Development reports to the CMO and is a member of the development leadership team. This leader partners with key stakeholders to define development strategy and oversee clinical development across Intellia’s portfolio, including hereditary angioedema (HAE) and transthyretin (TTR) amyloidosis. The role leads the cross-functional Clinical Development Team and provides strategic and medical leadership for product and pipeline candidates across disease areas, aligned with corporate strategy. It calls for a physician scientist with hands-on expertise and a collaborative, player-coach leadership style to advance product candidates. Intellia is a pre-commercial gene-editing company developing potential once-and-done therapies for serious diseases. Its in vivo gene-editing therapy for HAE is pending FDA review, and its two global Phase 3 trials in TTR amyloidosis—one in cardiomyopathy and one in polyneuropathy—are underway. The Head of Clinical Development provides medical oversight of clinical trials and supports scientific, regulatory, and cross-functional development activities throughout the portfolio.
Requirements
- MD, MD/PhD, or equivalent.
- Based in the greater Boston area and able to be regularly present at the Cambridge, Massachusetts office.
- 10+ years of experience in a clinical and/or medical function in the biopharmaceutical industry, including 7+ years of clinical development leadership experience.
- Strong critical-thinking skills and ability to synthesize complex information.
- Exceptional verbal and written communication skills, including ability to author documents under tight timelines.
- Highly organized, outcome-oriented, self-motivated player-coach with strong leadership, interpersonal, and conflict-management skills.
- Experience in innovative clinical study design, clinical data analysis, and publications; working knowledge of biostatistics and pharmacokinetics/pharmacodynamics.
- Deep understanding of drug development from pre-IND through BLA.
- Experience interacting with health authorities in the US and EU.
- In-depth knowledge of ICH-GCP and other applicable regulatory guidelines.
- Ability to travel domestically and internationally approximately 15%.
Nice To Haves
- Cardiovascular or rare disease experience is preferred but not required.
Responsibilities
- Build and lead a team of Medical Directors and Clinical Scientists, working with development stakeholders to define portfolio-wide development strategy and plans, including lifecycle management.
- Lead cross-functional Clinical Development Team meetings and provide strategic and medical leadership across products and pipelines, including HAE and TTR.
- Collaborate with the development leadership team to foster a collaborative culture and improve the effectiveness of the development team.
- Evaluate development strategies and plans rigorously, including through literature review and assessment of the development landscape and development and regulatory pathways.
- Engage external scientific and clinical trial experts, consultants, and regulatory consultants to develop scientifically robust study designs.
- Provide strategic guidance to medical directors and the clinical science team, including hands-on authorship of clinical and regulatory documents such as regulatory submission sections, study protocols, investigator brochures, and publications.
- Serve as lead author of clinical responses to regulatory authorities concerning protocols, INDs, BLA/MAA/JNDA, and other regulatory filings.
- Provide medical leadership and input to cross-functional activities, including business development, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs, and drug safety.
- Provide medical oversight of clinical trials, including study medical monitoring, adverse event reporting, and patient safety across development programs.
- Provide medical and scientific leadership in data analysis and interpretation while maintaining integrity, scientific rigor, and transparency.
- Serve as an internal and external spokesperson, as appropriate, communicating clinical results to audiences including investigators and KOLs.
- Work in compliance with applicable GCP and ICH regulations.
Benefits
- Performance-based annual cash bonus.
- New-hire equity grant.
- Eligibility to be considered for annual equity awards, with value determined annually at the Company’s discretion.
- Company benefits are referenced, but specific benefits are not listed in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
