Head of Clinical Development

How You Will Achieve More

We are a pre-commercial gene-editing company developing potential once-and-done therapies for serious diseases. Our in vivo gene-editing therapy for hereditary angioedema (HAE) is pending FDA review and poised to become the first in vivo gene-editing therapy, if approved, to reach the U.S. market. Our two global Phase 3 trials in transthyretin (TTR) amyloidosis: one in cardiomyopathy and one in polyneuropathy are well underway.

Head of Clinical Development, reporting to the CMO, will be a member of the development leadership team, accountable for partnering closely with key stakeholders in defining development strategy and oversight of clinical development activities across Intellia portfolio, including HAE and TTR. The successful candidate will be responsible for leading the cross-functional Clinical Development Team, providing strategic and medical leadership for clinical development activities of product and pipeline candidates across disease areas, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise and player coach collaborative leadership style in advancing product candidates to deliver life-changing medicines.

Responsibilities

• Build and lead a team of Medical Directors and Clinical Scientists, accountable for working collaboratively with key stakeholders in development to define development strategy and plan across company portfolio, including life-cycle management activities
• Lead cross-functional Clinical Development Team meetings, providing strategic and medical leadership of clinical development activities across company products and pipelines, including HAE and TTR
• Collaborate with other members of the development leadership team to contribute to building a collaborative culture and improving effectiveness of the development team
• Drive scientifically robust evaluation of development strategy and plans, including robust literature review to assess development landscape, evaluation of development and regulatory pathways
• Engage with external scientific and clinical trial experts, clinical and regulatory consultants, to develop scientifically robust study designs
• Provide strategic guidance and leadership to the medical director and clinical science team, including hands-on authoring of clinical and regulatory documents, such as clinical sections of regulatory submissions, study protocols, investigator brochures, publications
• Serve as lead author in clinical responses to regulatory authorities, related to review of protocols, INDs, BLA/MAA/JNDA, and other regulatory filings
• Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
• Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development program
• Provide medical and scientific leadership in data analysis and interpretation, maintaining integrity, scientific rigor, and transparency
• Serve as the spokesperson both internally and externally, as appropriate to communicate clinical results to a variety of audiences, including investigators and KOLs
• Work within compliance to all applicable GCP/ ICH regulations

About You

• MD, MD/PhD, or equivalent, based in greater Boston area
• Ability to be present regularly in the Cambridge MA office
• Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written, with ability to author documents under tight timeline
• 10+ years of experience in clinical and/or medical function in the biopharmaceutical industry, with 7+ years of clinical development leadership experience; cardiovascular or rare disease preferred but not required
• Highly organized, outcome-oriented, self-motivated player coach with strong leadership and interpersonal skills and effective conflict management skills
• Experience in innovative clinical study design, analysis of clinical data, publications, and 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 application regulatory guidelines
• Ability to travel domestically and internationally (~15%)