Head of Clinical Development

Intellia • Cambridge, MA

2d • Onsite

About The Position

Intellia is a pre-commercial gene-editing company developing potential once-and-done therapies for serious diseases. Its in vivo gene-editing therapy for hereditary angioedema (HAE) is pending FDA review, and its two global Phase 3 trials in transthyretin (TTR) amyloidosis are underway. The Head of Clinical Development reports to the CMO and serves on the development leadership team, partnering with key stakeholders to define development strategy and oversee clinical development across Intellia’s portfolio, including HAE and TTR.

The role provides strategic and medical leadership for clinical development activities across product and pipeline candidates and leads the cross-functional Clinical Development Team. The successful candidate is a physician scientist with hands-on expertise and a collaborative player-coach leadership style, focused on advancing product candidates and delivering life-changing medicines. The role also involves regular presence in the Cambridge, Massachusetts office and approximately 15% domestic and international travel.

Requirements

• MD, MD/PhD, or equivalent.
• Based in the greater Boston area and able to be present regularly in the Cambridge, Massachusetts office.
• At least 10 years of experience in a clinical and/or medical function in the biopharmaceutical industry.
• At least 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, and self-motivated, with strong leadership, interpersonal, and conflict-management skills.
• Experience with innovative clinical study design, clinical data analysis, and publications; working knowledge of biostatistics and pharmacokinetics/pharmacodynamics.
• Deep understanding of the drug development process 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

• Experience in cardiovascular or rare disease; preferred but not required.

Responsibilities

• Build and lead a team of Medical Directors and Clinical Scientists, working with development stakeholders to define portfolio development strategy and plans, including life-cycle management.
• Lead cross-functional Clinical Development Team meetings and provide strategic and medical leadership for development activities across products and pipelines, including HAE and TTR.
• Collaborate with development leadership to build a collaborative culture and improve the effectiveness of the development team.
• Evaluate development strategies and plans scientifically, including reviewing literature and assessing development landscapes and regulatory pathways.
• Engage external scientific and clinical trial experts, consultants, and regulatory consultants to develop scientifically robust study designs.
• Provide strategic guidance to the medical director and clinical science team, including hands-on authorship of clinical and regulatory documents such as submission sections, study protocols, investigator brochures, and publications.
• Serve as lead author of clinical responses to regulatory authorities regarding protocols, INDs, BLA/MAA/JNDA applications, 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 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.
• Communicate clinical results internally and externally, including to investigators and key opinion leaders.
• Work in compliance with applicable GCP and ICH regulations.

Benefits

• Performance-based annual cash bonus.
• New-hire equity grant.
• Eligibility for annual equity awards, with award value determined annually at the company’s discretion.
• Company benefits are referenced, but specific benefits are not listed in the posting.

What This Job Offers

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