The University of Texas MD Anderson Cancer Center
Director of Nonclinical Development
The University of Texas MD Anderson Cancer Center, Cambridge, Massachusetts, us, 02140
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr