VP/Head of Clinical Pharmacology
Vice President/Head of Clinical Pharmacology
Location: REMOTE (East Coast Based Biotech)
About Us:
Our team is partnered with a pioneering oncology biotech company dedicated to developing innovative therapies to improve the lives of cancer patients. They are committed to advancing their oncology pipeline through cutting-edge research and clinical development.
Position Overview:
The Vice President of Clinical Pharmacology will play a critical role in leading and shaping the company's clinical pharmacology strategy. This leadership position involves overseeing the design, development, and execution of clinical pharmacology studies to support the progression of our investigational therapies through clinical trials. The VP will work closely with cross-functional teams, including clinical development, regulatory affairs, and project management, to ensure the successful advancement of our oncology pipeline.
Key Responsibilities:
- Leadership & Strategy: Lead and manage the clinical pharmacology team to drive the clinical development strategy, integrating pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction assessments into all stages of clinical trials.
- Clinical Study Design: Develop and oversee the design and implementation of clinical pharmacology studies (e.g., dose escalation, PK/PD modeling) for oncology drug candidates, ensuring optimal dosing strategies and evidence generation.
- Regulatory Compliance: Provide pharmacology expertise and strategic guidance to ensure clinical studies meet regulatory requirements and align with global health authority expectations (FDA, EMA, etc.).
- Collaboration: Work cross-functionally with clinical development, medical affairs, regulatory affairs, and translational medicine teams to support the design, execution, and interpretation of clinical studies.
- Data Analysis & Interpretation: Oversee the analysis and interpretation of clinical pharmacology data to provide insights into dose optimization, safety profiles, and clinical pharmacology models.
- External Relationships: Foster relationships with external scientific and clinical experts, KOLs (Key Opinion Leaders), and regulatory agencies to ensure best practices and stay updated with industry trends.
- Team Development: Build, mentor, and grow a high-performing clinical pharmacology team while fostering a culture of collaboration, innovation, and excellence.
- Clinical Trial Management: Work closely with project management teams to ensure the timely execution of clinical trials, manage budgets, and ensure resources are appropriately allocated.
- Publications & Presentations: Contribute to scientific publications and presentations at industry conferences to enhance the company's scientific reputation and communicate clinical pharmacology findings.
Qualifications:
- PhD or PharmD in Pharmacology, Pharmaceutical Sciences, or a related field.
- Minimum of 13 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in a senior leadership role in clinical pharmacology.
- Expertise in oncology pharmacology and a strong understanding of clinical trial design and regulatory requirements.
- Experience leading IND/NDA/BLA regulatory submissions
- Proven track record of leading and managing clinical pharmacology teams.
- Excellent communication, collaboration, and leadership skills.
- Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
Benefits:
- Competitive salary and equity compensation
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Generous paid time off and holidays
- Professional development opportunities