Senior/Executive Director of Toxicology

About the Company

Emerging biotechnology (BioTech) firm specializing in innovative therapeutics for serious musculoskeletal diseases

Industry Pharmaceuticals

Type Privately Held

Founded 2018

Employees 51-200

Categories

Pharmaceuticals Biotechnology Health Care Academic Research Medical Conditions Therapeutics Clinical Care Health International Business Manufacturing Medicine Chemical Products

Specialties

musculoskeletal rare diseases bone cartilage and muscle

About the Role

The Company is in search of a Senior/Executive Director of Toxicology to play a pivotal role in the development of breakthrough therapies for musculoskeletal diseases. The successful candidate will be responsible for leading and shaping the nonclinical safety strategy, ensuring that all toxicology efforts are scientifically robust, and compliant with regulatory requirements. This includes the development and execution of non-clinical safety and toxicology strategies for early- and late-stage biologic programs, as well as the design, commissioning, and oversight of various toxicology studies. The role also involves close collaboration with cross-functional teams, preparation of toxicology sections for regulatory submissions, and representing the company in interactions with health authorities.

Applicants must have a Ph.D., DVM, or equivalent in toxicology, pharmacology, or a related field, with a minimum of 12 years of experience in the biotech/pharma industry, particularly in biologics. The ideal candidate will have a proven track record in toxicology strategy for IND-enabling studies and clinical-stage biologics, a deep understanding of regulatory toxicology requirements, and experience with global regulatory submissions. Strong leadership, communication, and team-building skills are essential, as is certification as a Diplomate of the American Board of Toxicology. The role requires the ability to influence cross-functional teams and executive stakeholders, manage CROs and external partnerships, and stay abreast of emerging trends in biologics toxicology to integrate innovative approaches where appropriate.

Hiring Manager Title SVP, Head of Translational Science

Travel Percent 20%

Functions

Medical Care/Hospital Administration Non-Profit Management