Director / Vice President, Nonclinical Development

Divergence Labs; New York (NY); On-site; USD 260,000 - 360,000; Full time

Job summary

Divergence Labs is seeking a full-time Director/VP of Nonclinical Development to own nonclinical development and regulatory strategy across our candidate molecules. The role requires 10+ years in biologics with IND/CTA experience and oversees CROs, regulatory interactions, and cross-functional collaboration to drive first-in-human programs.

The ideal candidate will lead a small integrated team, write nonclinical sections for briefing packages, and shape automation of development processes with

Qualifications

• PhD/PharmD/DVM/MD with 10+ years in nonclinical development and/or regulatory affairs for biologics.
• Led nonclinical package for at least one biologic through IND/CTA approval.
• Experience planning and leading formal agency interactions (pre-IND, scientific advice) and authoring briefing packages.
• Hands-on CRO management: study design, protocol review, monitoring, data review and budget ownership.
• Knowledge of PK/PD, DMPK, bioanalytical methods and GLP requirements.
• Experience with nonhuman primate and rodent toxicology programs, including dose-range finding.

Responsibilities

• Own the nonclinical development strategy for each program, aligning pharmacology, PK/PD, safety pharmacology and GLP toxicology with regulatory plans.
• Design and oversee CRO studies; select models; manage data, and finalize reports across therapeutic areas.
• Lead regulatory strategy and agency interactions; support pre-IND and submissions end-to-end.
• Author nonclinical overviews, summaries, and study reports and contribute to Investigator's Brochures.
• Set first-in-human dose and exposure margin analyses with clinical teams.
• Build and manage external network of CROs; ensure GLP compliance and on-time delivery.
• Collaborate with discovery and CMC to align with developability and testing in toxicology.
• Establish function standards, SOPs and data/document control.
• Lead and grow a small, high-caliber nonclinical and regulatory team.

Skills

Nonclinical development

Regulatory strategy

Biologics IND/CTA

CRO management

Regulatory writing

Education

PhD/PharmD/DVM/MD in toxicology or related field

Job description

Director / Vice President, Nonclinical Development

Divergence Labs is hiring a full-time Director / Vice President of Nonclinical Development to own nonclinical development and regulatory strategy across the portfolio of candidate molecules we discover. We are seeking an experienced leader with a track record of achievement in drug development, including but not limited to 10+ years of industry experience taking biologics from candidate selection through IND/CTA-enabling studies and into first-in-human trials. The role will manage all nonclinical studies across therapeutic areas for Divergence's programs and will support our regulatory interactions. We are open to talented team members in San Francisco, San Diego, Minneapolis, Boston, New York, or Cambridge, UK. We expect the role will require regular travel to contract research organization (CRO) partners globally.

Divergence Labs is a biotechnology company on a mission to reshape standard of care across all disease areas. Founded in 2025 by an interdisciplinary team of biotechnology investors, drug hunters, hardware engineers, and machine learning scientists, we have assembled a high-performance team that unites investment acumen, world-class protein engineering, advanced computational research, and translational medicine to build repeatable methods for discovering new medicines which transform patient care. Divergence has presence across San Francisco, CA, Minneapolis, MN, New York, NY, and Cambridge, UK. Although we have not publicly disclosed our financing details, Divergence is well capitalized and backed by world-leading investors, each of whom are among the earliest investors in companies such as Isomorphic Labs, Xaira Therapeutics, Coefficient Bio/Anthropic, and Chai Discovery, among others. We are among a select set of biotechnology companies with a strategic relationship with Anthropic.

We are committed to identifying, developing, and rewarding world-class talent, and, as such, all positions at Divergence Labs come with market-leading compensation.

The Role

We are hiring our first dedicated nonclinical leader. Divergence's discovery platform is now producing development candidates across multiple therapeutic areas, and this role exists to turn those candidates into IND- and CTA-ready programs. You will own the nonclinical development plan for every program: pharmacology, PK/PD, biomarker analysis, safety pharmacology and GLP toxicology, together with the regulatory strategy tying them to a first-in-human trial.

Our nonclinical studies are executed through external partners. You will design the studies, select and manage the CROs that run them, ensuring the data are generated to the standard of a sponsor who will have to defend every data point in front of an agency. You will work in close partnership with our antibody discovery, protein engineering and clinical development, and CMC colleagues so that candidates are characterized, dosed and documented to one consistent standard across programs.

This is a hands-on leadership role in a small, integrated team. You will be the person who writes the nonclinical sections of the briefing package, sits across from the agency at the pre-IND meeting, and tells the company when a program is ready. Additionally, you will have an opportunity to shape the frontier of automation of the development process with the world's most capable artificial intelligence tools.

Ideal Candidate Profile

We are looking for an experienced nonclinical and regulatory leader who thrives in a small, integrated team and wants end-to-end ownership of how Divergence's molecules reach the clinic: someone who has led biologics through IND/CTA, is fluent across toxicology, DMPK, bioanalytics and pharmacology, and is comfortable standing up the function from first principles.

Key Responsibilities

• Own the nonclinical development strategy: Define the integrated nonclinical plan for each program (pharmacology, PK/PD, immunogenicity risk, safety pharmacology, dose-range-finding and GLP toxicology) aligned to the target product profile and the intended first-in-human design.
• Run every nonclinical study across the portfolio: Design protocols, select species and models, manage study execution at CROs, review data as it comes in and own the final reports, across all therapeutic areas and modalities.
• Drive regulatory strategy and agency interactions: Support pre-IND, Type B/C and scientific-advice meetings with FDA, MHRA and EMA; author briefing documents; own IND and CTA submissions end to end, with external regulatory support where needed.
• Author the regulatory documents: Write and review nonclinical overviews, summaries and study reports (CTD Modules 2.4, 2.6 and 4), the nonclinical sections of Investigator's Brochures, and responses to agency questions.
• Set the first-in-human dose and safety margins: Lead PK/PD modeling, MABEL/NOAEL-based starting-dose justification and exposure-margin analysis in partnership with clinical development and translational colleagues.
• Build and manage the external network: Qualify, contract and manage toxicology, DMPK, bioanalytical and safety-pharmacology CROs; negotiate budgets and timelines; audit for GLP compliance; and hold partners accountable for quality and schedule.
• Partner with discovery and CMC: Feed developability and safety considerations (cross-reactivity, Fc effector function, immunogenicity, target biology in tox species) back into candidate selection, and coordinate with CMC on test-article supply, comparability and specifications for GLP and clinical material.
• Establish the function's standards: Set up SOPs, study templates, data management and document control for nonclinical and regulatory work.
• Lead and grow the team: Build a small, high-caliber nonclinical and regulatory group as the portfolio expands, and mentor colleagues across the company on development thinking.

Required Experience

• PhD, PharmD, DVM or MD in toxicology, pharmacology, pharmaceutical sciences or a related discipline, plus 10+ years of industry experience in nonclinical development and/or regulatory affairs for biologics.
• Direct experience leading the nonclinical package for at least one biologic (monoclonal antibody, antibody fragment, bispecific or fusion protein) through IND clearance or CTA approval.
• Working command of ICH S6(R1), S9, M3(R2) and S7A, GLP requirements, and the CTD structure.
• Experience planning and leading formal agency interactions (pre-IND, Type B/C, scientific advice) and authoring the briefing packages behind them.
• Hands-on CRO management: study design, protocol review, monitoring, data review, report sign-off and budget ownership.
• Large-molecule DMPK and bioanalytical understanding: PK/PD and TK, ADA and neutralizing-antibody assays, species selection and tissue cross-reactivity.
• Experience running non-human primate and rodent toxicology programs, including dose-range-finding and GLP pivotal studies.
• Regulatory-grade writing: able to produce overviews, summaries and briefing documents that go out without heavy editing.
• Excellent interpersonal and communication skills, appropriate for a small, integrated team where cross-domain conversation happens daily.

Additional Experience Welcomed

• Nonclinical programs in more than one therapeutic area, particularly immunology and inflammation, oncology and immuno-oncology.
• Experience with novel formats (VHHs, multispecifics, Fc-engineered molecules, receptor agonists and ligand mimics) and the nonclinical questions they raise (cytokine release, on-target toxicity in the tox species, surrogate molecules).
• Ex-US submissions and agency interactions (MHRA CTA, EU Clinical Trials Regulation, Health Canada, Australian CTN).
• Quantitative translational modeling (PBPK, QSP, population PK) and clinical pharmacology input to first-in-human design.
• Experience putting AI and large language model tools to work in literature review, study design and regulatory writing.

Cultural Profile

• Intellectual Honesty: We value candid and open discussion. Our team admits when wrong, advocates when right, and never shies away from constructive feedback.
• Bias for Action: We take initiative and ownership of our work, actively seeking out new ideas, and taking well-researched and smart risks.
• Team First Attitude: We win as a team and lose as a team. There are \"no egos\" at Divergence Labs, and we understand great ideas can come from anywhere.
• Independence of Thought: We think critically and challenge assumptions. When it suits us, we develop hypotheses that may run counter to consensus, \"zigging while others are zagging.\"
• Resilience: Drug development is a tough sport. We persevere in the face of challenge.
• Embrace the Unfamiliar: We are humbled and excited by how much there is left to learn.

Divergence Labs is an equal-opportunity employer. We are committed to building a team that reflects a wide range of backgrounds, perspectives, and experiences.