Director of Toxicology & Preclinical Pharmacology

Proclinical is seeking a Director of Toxicology & Preclinical Pharmacology for a cutting-edge biopharmaceutical company located in Germantown, MD.

Must be eligible to work in the US.

Job Responsibilities:

• Leadership - provide expert scientific leadership in the areas of toxicology and DMPK to program teams, and ensure preclinical packages support clinical development.
• Toxicology - Lead the development and execution of an integrated and scientifically sound nonclinical safety strategy from lead identification through clinical trial conduct.
  • Design, operationalize, and interpret studies to evaluate clinical candidate toxicities, therapeutic index, and overall risk/benefit assessment.
  • Key contributor to the selection and timely development of clinical candidate through close interaction with discovery, CMC, clinical and regulatory functions
  • Generate concise safety assessments/reports for internal decision making, as well as regulatory submission documentation to facilitate health authority reviews and approval processes in all phases of drug development.
  • Provide strategic advice to project teams and senior leaders including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
• DMPK - in partnership with project team, apply understanding of PK/PD and ADME to support product advancement and evaluation.
  • Design, operationalize, and analyze DMPK studies to elucidate metabolic fate, drug-drug and transporter interactions.
  • Apply state-of-the-art allometric scaling and dose prediction models.
  • Assist project team in developing clinical PK and PK/PD plan
• Translational and Biomarker plan - contributes to project transitions from pre-clinical to Clinical Development in close collaboration with discovery and clinical colleagues.
• Regulatory - manage the preparation and/or presentation of relevant sections of external documents (e.g. Investigator's Brochure, IND/CTA, PIP, CTD, etc.). Review all regulatory and health authority documents for the relevant RAs
• CRO selection & oversight - principal accountability for delivering critical project data through a network of external study providers. In collaboration with project teams, select CROs and participate in study design, troubleshooting, data analysis and interpretation, QC/audit and oversight of study reports.
• Flexibility - must be able to contribute to a portfolio of projects spanning early and late preclinical discovery, translational medicine, and clinical development.

Skills and Requirements:

• PhD, DVM or equivalent and advanced experience in toxicology and/or pharmaceutical sciences
• A minimum of 10 years of experience in the pharmaceutical industry, including significant experience in drug discovery and development, preferably in autoimmunity, infectious diseases, or oncology therapeutic areas, and across several therapeutic modalities.
• GLP knowledge/experience is a plus.
• Board certification such as a DABT is an advantage.
• Demonstrated leadership skills and desire and ability to perform well in a fast-paced environment with a sense of urgency
• Experience leading drug discovery and development programs through significant milestones (candidate identification, first-in-man studies, proof-of-concept)
• Strong understanding of global regulatory guidance's that shape the toxicology program strategy
• Knowledge of DMPK science & some experience in DMPK drug discovery
• Strong interpersonal skills and team player: maintain effective interactions with internal and external collaborators
• Strong passion for pharmaceutical innovation
• Strong communication skills, both verbal and written
• Excellent self-management and organizational skills
• Experience in autoimmunity and/or immunotherapeutic drug development and/or small molecule or nanoparticles modalities is an advantage.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at +(1) 857-362-9542 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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