We're looking to connect with a seasoned clinical pharmacologist who wants to join an innovative bio-therapeutic company who's developing groundbreaking therapies within Oncology and backed up by their 30+ approved products.
Position Overview: This candidate will lead and oversee the clinical pharmacology strategy and operations for a dynamic and innovative biopharmaceutical company. This senior leadership role requires a seasoned expert in clinical pharmacology to drive the development and execution of comprehensive pharmacokinetic and pharmacodynamic strategies, supporting the advancement of novel therapeutic candidates from early development through regulatory approval.
Key Responsibilities:
- Develop and implement clinical pharmacology strategies to support the company's drug development programs.
- Oversee the design, execution, and analysis of clinical pharmacology studies, including Phase I-IV clinical trials.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment and integration of clinical pharmacology activities.
- Provide expert guidance on dose selection, study design, and data interpretation to optimize clinical trial outcomes.
- Lead the preparation of clinical pharmacology sections for regulatory submissions, including INDs, NDAs, and BLAs.
- Serve as a key liaison with regulatory agencies, presenting clinical pharmacology data and addressing regulatory queries.
- Mentor and develop a high-performing team of clinical pharmacologists and pharmacometricians.
- Stay abreast of industry trends and advancements in clinical pharmacology to drive innovation and maintain competitive advantage.
Qualifications:
- Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmacokinetics, or a related field.
- A minimum of 10 years of experience in clinical pharmacology within the biopharmaceutical industry.
- Proven track record of successful leadership and management of clinical pharmacology programs.
- In-depth knowledge of pharmacokinetics, pharmacodynamics, and modeling and simulation techniques.
- Strong understanding of regulatory requirements and guidelines for drug development and approval.
Please apply or send your cv with your availability to chat.
