Director of Nonclinical Development

Job Title: Director, Nonclinical Development

Job Number: 36509

Location: Cambridge, MA

Job Description

We are seeking an experienced and motivated Director of Nonclinical Development to lead and execute the company’s nonclinical strategy, enabling progression of mRNA-based therapeutics from discovery through IND-enabling studies and first-in-human (FIH) clinical trials. This role will be critical to the success of our pipeline and will collaborate cross-functionally with discovery, CMC, clinical, and regulatory colleagues to support program advancement and global regulatory submissions (US, EU, AUS).

Responsibilities

• Lead the nonclinical strategy and execution for mRNA/oligonucleotide-based programs, including design, conduct, data interpretation, and reporting of FIH studies.

• Design and oversee nonclinical safety, pharmacology, PK, and biodistribution studies to support program development from research to clinical stages.

• Author and contribute to regulatory documents including INDs, CTAs, and CTNs, and participate in regulatory agency interactions (FDA, EMA, TGA).

• Manage timelines, deliverables, and communication across cross-functional teams to ensure program alignment and execution.

• Serve as the nonclinical representative on cross-functional program teams and lead functional subteams as needed.

• Oversee external partnerships, including CROs and consultants, ensuring high-quality data and timely execution.

• Stay current with emerging nonclinical and regulatory trends in RNA-based therapeutics.

• Ensure compliance with GLP and other regulatory standards.

Required Skills

• BS/MS in Biochemistry, Molecular Biology, Toxicology, Pharmacology, or related field; PhD or DVM strongly preferred.

• Minimum of 10 years of industry experience with a proven track record in nonclinical drug development from early discovery to clinical trials.

• Experience with mRNA, oligonucleotide, or gene therapy modalities.

• Strong experience leading nonclinical efforts for FIH trials, including study design and regulatory strategy.

• Demonstrated success in authoring IND, CTA, and CTN submissions.

• Experience working with CROs and external partners to conduct GLP and non-GLP studies.

• Effective communicator with ability to work across teams and lead functional groups.

• Strong project management skills: ability to track timelines, deliverables, and results.

• Deep understanding of US, EU, and AUS regulatory environments.

Nice to have

• Experience leading nonclinical safety/toxicology for later-stage development.

• DABT certification.

• Previous program leadership and/or managerial experience.

What We Offer

• Opportunity to join a high-impact team at the ground floor of a rapidly growing mRNA biotech

• Competitive compensation and equity

• Benefits package including health, dental, vision, and more