Position Summary:

The Director of Toxicology will provide oversight for the design and execution of non-clinical safety programs to support the development of drug candidates, including off-target risk assessment and de-risking from discovery to early/late development programs and market authorization. This candidate will play a crucial role in study design, data review, safety assessment, ensuring the safety and efficacy of Biomea’s products while complying with regulatory requirements.
The Director of Toxicology will serve as the primary point of contact between global project teams and Nonclinical Drug Safety (NDS) and is responsible for developing nonclinical safety strategies that support the clinical development plan in oncology, metabolic, and additional non-oncology indications. This candidate will also be the primary interface with external stakeholders including global health authorities, third party organizations (TPO), and CROs, consolidating safety data from nonclinical studies into regulatory submissions as needed.

Essential Responsibilities

Study Design, Execution & Protocol Development:

• Design, oversee and execute preclinical toxicology studies, safety assessments, non-clinical safety studies and detailed protocols at appropriate stages, to support asset progression through development.
• Partner cross functionally to assess technical ability of TPO to meet scientific requirements of the protocol.
• Prior to study initiation, ensure protocol documentations are accurately provided, possibly visiting TPOs during study to ensure protocol procedure adherence and alignment with GLP expectations and technical capabilities.
• Serve as first line of contact for study-related issues with TPOs, resolve scientific or logistical study protocol concerns, and assess impact on study integrity.
• Determine appropriate study endpoints, select appropriate animal models, and manage the execution of these studies either internally or through external CROs or TPOs
• Coordinate internal review processes to ensure compliance with study achievements, metrics, and corporate timelines.

Data Review

• Conduct In-Vivo Pharmacokinetic, Pharmacodynamic and Toxicology study design and data review, serving as the main point of contact for receiving, reviewing, and interpreting study data.
• Compile and convey all report comments to the Study Director at the TPO.

Safety Assessment:

• Assess the potential risks and safety liabilities associated with new products developed by Biomea.
• Conduct toxicological evaluations and risk assessments, studying the effects of substances on various biological systems to determine safety profiles.
• Identify potential hazards associated with product exposure and determine appropriate risk mitigation strategies.
• Evaluate the potential for adverse effects in different populations, such as vulnerable or sensitive subgroups.
• Develop and lead investigative studies to support investigations on mechanisms of toxicity.

Regulatory Compliance:

• Maintain abreast of regulatory guidelines, ensuring Biomea’s products comply with regulatory requirements set forth by agencies such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other relevant regulatory bodies.
• Independently consolidate safety findings into regulatory documents, including briefing books, investigational new drug applications (INDs), Investigator brochures (IBs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), while maintaining effective communication with agencies.

Cross-functional Collaboration:

• Collaborate with cross-functional departments (including Research, Pharmacology, DMPK, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance) to implement discovery & development of toxicology strategies to enable the progression of optimized drug candidates and ensure that toxicological considerations are integrated into all stages of product development.
• May work closely with Therapeutic Area Leads responsible for knowledge of a broad therapeutic area and related internal portfolio.

Communication and Reporting:

• Serve as NDS Therapeutic Area lead/Biomea Toxicology representative, and/or provide guidance and subject matter expertise (SME) in NDS relevant area of expertise on multiple interdisciplinary Project Teams.
• Act as the company toxicology representative on external pre-clinical safety related consortia, addressing questions in interactions with FDA, EMA and other authorities on preclinical safety topics.
  • Prepare and present toxicology reports, updates, regulatory submissions, integrated safety assessments, and recommendations to internal stakeholders (i.e. Project teams, senior management), and external stakeholders (i.e. regulatory agencies, investors, and partners) in alignment with project goals and impact on asset strategy.
  • Contributes to department administrative tasks, demonstrating fiscal responsibility with respect to cost of experiments, technology, external collaborations, and travel.

Education and Experience Requirements

• PhD or equivalent degree from an accredited institution in areas of Toxicology or Pharmacology, with at least 10 years related experience in biotech/pharmaceutical industry setting.
• DABT certification is preferred.
• Proven expertise in toxicology, pharmacology, approaches to discovery toxicology, regulatory affairs, submission documentation, and drug development processes, as well as strong leadership and communication skills.
• Experience with NDA, BLA, MAA submissions advantageous.
• Knowledge of specific platforms (e.g. viral and gene therapies, monoclonal antibodies, ADCs) or therapeutic areas is highly desirable.
• Routinely apply optimal tactical practices that impact projects, filings, and other disciplines.
• Demonstrates ability to work effectively in a cross-functional team environment.
• Excellent written and oral communication skills with strong attention to detail in an interdisciplinary environment.
• Familiarity with Regulatory policies and procedures related to GLP study design and reporting.
• Current understanding of trends in nonclinical safety assessment within the TPO landscape.
• Experience with In-Vivo Pharmacokinetic, Pharmacodynamic and Toxicology study design and data review.

Industry:

• Biotechnology

Employment Type:

• Full-time

Equal Employment Opportunity:At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristics.

The anticipated salary range for qualified candidates for this role is $225,000 to $260,000. An individual’s position within the range is influenced by multiple factors, including education, relevant work experience, tenure, and market dynamics. The actual salaried offered will be based on these factors. In addition to the competitive base salary, we all offer a performance-based discretionary bonus program, equity awards and comprehensive benefits program.