We have a current opportunity for a Director Clinical Pharmacology on a permanent basis. The position will be based in New York/ NJ office locations (3x a week required). For further information about this position please apply.
Job Title: Director of Clinical Pharmacology
Location: New Jersey/NY (3x a week required)
Company Overview: This organization consists of teams that are rapidly advancing numerous preclinical projects covering a broad range of therapeutic areas like Oncology, Immunology, and Neuroscience.
Job Summary: The Director of Clinical Pharmacology will be responsible for designing and implementing clinical pharmacology strategies to support the development of our pipeline products. This role will involve close collaboration with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure the successful execution of clinical trials and regulatory submissions.
Key Responsibilities:
- Lead the design and execution of clinical pharmacology studies, including first-in-human, dose-escalation, and drug-drug interaction studies.
- Support Clinical Pharmacology Project Leads for the use of quantitative approaches to describe the relationship between drug exposure and response
- Develop and implement clinical pharmacology plans to support regulatory submissions and product labeling.
- Provide clinical pharmacology expertise to cross-functional project teams.
- Build Modeling and Simulation in the Clinical Pharmacology group
- Generate and interpret pharmacokinetic (PK) and pharmacodynamic (PD) data.
- Plan, write, and review pharmacometrics aspects in relevant clinical documents such as study protocols, analysis plans, clinical study reports, and regulatory documents
- Prepare and review clinical pharmacology sections of regulatory documents, including INDs, NDAs, and BLAs.
- Stay current with scientific literature and advancements in the field of clinical pharmacology.
- Mentor and develop junior clinical pharmacology staff.
Qualifications:
- Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmacokinetics, or a related field.
- Minimum of 10 years of experience in clinical pharmacology within the biotech or pharmaceutical industry.
- Proven track record of designing and executing clinical pharmacology studies.
- Hands-on experience with PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, SimCyp, GastroPlus, etc.) is a must.
- Experience with regulatory submissions and interactions with regulatory agencies.
- Knowledgeable in quantitative pharmacology and strong hands-on modeling and simulation experience with PK/PD analysis to inform dose selection, safety profile characterization, and product labeling.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively in a fast-paced, collaborative environment.
Benefits:
- Competitive salary and benefits package.
- Opportunity to work in a cutting-edge biotech company with a mission to improve patient lives.
- Collaborative and supportive work environment.
- Professional development and growth opportunities.
