Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Tunnell Consulting is working with one of their clients to fill the role of Director, Toxicology and Translational Sciences. This role is hybrid role. Desired geographic location: Batimore/MD Washington DC Metro Area. This is a direct hire role.

Job Title: Director, Toxicology and Translational Sciences

Summary:
In this role, the Director will oversee non-clinical development programs, ensuring scientific expertise from product discovery through clinical trials. A key focus will be on creating strategic plans to support regulatory submissions, particularly regarding safety and pharmacology.

Key Responsibilities:

Act as a representative on core teams for non-clinical safety and translational sciences.
Lead pharmacology and toxicology strategies for clinical trials.
Develop non-clinical plans for regulatory submissions (IND, BLA).
Collaborate with teams to design non-clinical strategies for initial human trials.
Manage pharmacology/toxicology studies, including model selection, data analysis and risk assessment.
Prepare technical documents (study reports, safety assessments) for regulatory submissions.
Ensure all assessments meet regulatory standards (FDA, EMA, ICH).
Work with Bioanalytical and Clinical teams to align biomarkers for studies.
Conduct risk assessments and advise on safe clinical trial doses.
Collaborate with various departments to implement safety strategies.
Evaluate and monitor contracted research organizations (CROs).
Prepare and review scientific publications and presentations.
Present findings to senior management and regulatory bodies.
Keep up-to-date with toxicology literature and regulations.

Qualifications:

Ph.D. (or equivalent) in Toxicology, Pharmacology, or a related field (Master’s with relevant experience is acceptable).
10+ years of experience in pharmacology/toxicology and drug development.
Experience writing regulatory summaries (IND, BLA) and knowledge of guidelines.
Strong technical writing skills for regulatory documents and publications.
Expertise in toxicology study designs and safety assessments.
Good analytical skills for pharmacological and toxicological data.
Experience coordinating non-clinical studies is preferred.
Gene therapy experience a must; (AAVs or viral vectors) is a plus.
Proficient in MS Office and document management systems.
Willingness to travel for study monitoring.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.

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