Our client is a biotechnology company focused on oncology. They have asked us to assist them in their search for a Senior Director, Clinical Pharmacology.  

Major tasks and responsibilities include:

• Formulates and executes the clinical pharmacology strategy for the company's drug development programs, taking into consideration the unique characteristics of each drug candidate. Provides expert guidance on study design, PK/PD modeling, dose selection, and drug-drug interaction assessments.
• Utilizes prior knowledge and experience with accelerated approvals to guide the clinical development plans, including identification of potential accelerated approval pathways and appropriate endpoints for regulatory submissions.
• Oversees relationships with external vendors, including clinical research organizations (CROs), pharmacokinetic service providers, and individual consultants. Ensures timely and high-quality deliverables, manages vendor contracts, and drives vendor selection processes.
• Leads the preparation of clinical pharmacology components for New Drug Applications (NDAs) or Biologics License Applications (BLAs). Collaborates with cross-functional teams to develop comprehensive study reports, ensuring adherence to regulatory guidelines and requirements.
• Establishes and leads the clinical pharmacology function. Establishes vision, strategy, goals, and deliverables for function. Defines processes and workflow so that other departments can work in an integrated manner with clinical pharmacology.
• Stays updated on the latest advancements and regulatory trends in clinical pharmacology, small molecule and biologic therapeutics, and accelerated approval pathways. Contributes to the scientific community through publications, conference presentations, and participation in industry forums.
• Enhances the environment of the Chief Medical Officer team by being a good steward of the corporate values and mission. Actively partners with Clinical Development, Clinical Operations, Nonclinical Development, Pharmaceutical Sciences, Discovery and Translational Sciences functions in driving assets and company strategy to fruition.
• Continuously develops and maintains strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.

We seek candidates with the following qualifications:

• A PhD or PharmD in Pharmacology, Pharmaceutical Sciences, or a related field is required.
• Must have extensive experience (at least 10 years) in clinical pharmacology within the pharmaceutical or biotechnology industry.
• Requires strong expertise in small molecules and biologics drug development, including knowledge of PK/PD modeling, drug-drug interactions, and regulatory guidelines.
• A proven track record of successful contributions to accelerated approval pathways and regulatory submissions is required.
• Must have demonstrated experience in leading and managing cross-functional teams and external vendors.
• Requires excellent communication skills, both written and verbal, with the ability to effectively present complex scientific information to diverse audiences. Substantial technical writing experience is essential. IND and NDA submission experience is preferred.
• Requires strong leadership abilities, with the capacity to inspire and motivate team members towards shared goals. Must have effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams.
• Must have an analytical mindset and ability to think strategically, identifying risks and opportunities in drug development programs.
• Must be highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.

 

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.