Director / Senior Director, Toxicology

We are seeking an experienced leader in toxicology to build and direct nonclinical safety strategy as Prolynx advances its ultra-long-acting, hydrogel-based conjugate therapeutics toward and through the clinic. You will lead the toxicology function and address needs across the portfolio, addressing systemic safety of peptide payloads, and you serving as the primary nonclinical safety voice on program teams, with regulatory agencies, and with senior leadership.

Prolynx has an efficient, outsourced model for nonclinical safety. You will lead a global network of toxicology CROs and work hand in hand with expert nonclinical consulting partners to design, execute, and monitor critical studies.  You will author reports and regulatory documents, ensure that all studies are designed well, conducted to GLP standards, and accepted by regulators. As a member of the Preclinical Leadership Team, you will serve as a senior scientific voice shaping program strategy, resourcing and go/no-go decisions alongside the Chief Scientific Officer and other functional leaders.

• Define stage specific safety data needed and give clear go/no-go recommendations.
• Conduct exploratory safety studies effectively in a timely manner to shape candidate selection
• Proactively build safety plans for both preclinical and clinical development.
• Design strategies and studies as appropriate and in line with regulatory guidance and the 3Rs.
• Take ownership of preclinical development activities on teams as functional team member/PTL.
• Address class effects of target payloads, such as exaggerated pharmacology limiting doses in animals, and set appropriate safety margins.
• Assess immunogenicity and hypersensitivity risks.
• Design combination toxicology strategies for pharmacokinetically matched multi-payload drugs.

• Select, qualify, and audit CROs globally, confirming GLP compliance, data integrity and the acceptability of study data to FDA and other regulators.
• Manage logistics for global studies, including shipments, and on-site/remote study monitoring.
• Arrange independent pathology peer review and ensure SEND-compliant datasets for regulatory submissions.
• Work with partners, review reports and regulatory writing, and integrate with safety strategy.

• Author and critically review nonclinical safety sections of IND and IMPD filings, Investigator's Brochures and other documents, and lead pre-IND and other regulatory nonclinical interactions.
• Assess or work with DMPK to inform toxicokinetics and safety margins against projected human exposure, and work with Clinical Development colleagues on first-in-human dose selection and safety monitoring.
• Work with CMC on impurity qualification and safety of formulation and manufacturing changes.
• Present integrated safety risk assessments to executive leadership.

• PhD, DVM or equivalent in toxicology, pharmacology or a related discipline.
• Minimum 10 years (12+ strongly preferred) of toxicology experience in biotech or pharma industry, including leading nonclinical safety strategy for programs through clinic.
• Extensive knowledge of GLP study design, safety pharmacology and regulatory expectations for nonclinical safety packages, including ICH M3(R2), S7A/B and related guidance.
• Directly authored nonclinical sections of IND or IMPD submissions with record of participation in health authority interactions preferred.
• Managed studies at CROs international with strong record of execution and budget control.
• Set scientific strategy and influence program and portfolio decisions at a leadership level (functional leadership or leadership as a project team lead).

• DABT board certification.
• Experience with peptide, biologic, or controlled-release and depot drug products, including local tolerability and delivery-system biocompatibility.
• Experience with incretin, amylin or other metabolic therapies.
• Experience qualifying degradation products, impurities or PEGylated materials.
• Experience with CRO auditing and data-integrity review.
• Experience with 505(b)(2) or other bridging strategies for known active ingredients.
• Familiarity with new approaches or methodologies that reduce animal use.
• Strong statistical skills for in vivo study design and analysis, and can integrate complex data sets to inform drug development strategy.
• Hands-on PK/PD or exposure-response modeling (for example Phoenix WinNonlin, NONMEM, Monolix or R) and calculation of human dose projection.

• Fluid, clear and articulate communication style.
• Poised working with CROs, consultants and regulators across cultures and time zones.
• Experience with diverse perspectives and working collaboratively on multidisciplinary teams.
• Demonstrated track record of scientific rigor and creativity in carrying out research.
• Excel in nimble, fast-moving and outsourced environments.

Please send your CV and a short cover letter describing your most relevant nonclinical safety programs when applying.

We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.