Senior Director Clinical Pharmacology

Job Title: Senior Director Clinical Pharmacology

Job Number: 35217

Location: Remote, 

Job Description

One of our favorite Biotech clients is seeking an experienced and innovative Senior Director of Clinical Pharmacology to join their Development team. In this role, you will lead clinical pharmacology efforts, support late-stage drug development, and contribute to business development activities. Your work will be crucial in advancing their mission to deliver new treatments to patients faster and more efficiently through their cutting-edge, tech-enabled drug development platform. This role reports to the VP of Translational Medicine, and you will be a key member of the Development team.

Responsibilities

• Develop clinical pharmacology strategies that align with target product profiles, program goals, and regulatory strategies.

• Collaborate with the Clinical Development team to define biopharmaceutics and clinical pharmacology studies necessary for NDA submissions and drug labeling.
• Lead clinical pharmacology activities supporting late-stage drug development across multiple therapeutic areas.
• Design and oversee the execution of clinical pharmacology studies to support clinical development and regulatory submissions.
• Plan, design, and analyze Phase 1-IV PK and PD studies, including the development of appropriate population PK models.
• Contribute clinical pharmacology expertise to due diligence efforts for potential in-licensing opportunities.
• Serve as the primary clinical pharmacology lead and actively participate in cross-functional teams to integrate modern clinical pharmacology principles into project plans and study designs.
• Provide scientific leadership in interactions with regulatory agencies and external partners.
• Develop and implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology studies.
• Manage resources, timelines, and budgets for clinical pharmacology activities.
• Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation.
• Represent the company’s clinical pharmacology capabilities at scientific conferences and partner meetings.
• Prepare Clinical Pharmacology Sections of regulatory documents, including INDs, NDAs, and briefing documents.

Required Skills

• PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, including a minimum of 10 years in a supervisory role overseeing clinical pharmacology activities.

• Proven track record in leading clinical pharmacology efforts in late-stage drug development.
• Strong understanding of regulatory requirements for clinical pharmacology studies supporting clinical development.
• Proficient in the use of PK and PK/PD modeling software tools.
• Experience in due diligence activities for in-licensing opportunities.
• Excellent communication and leadership skills.
• Ability to work effectively in a fast-paced, cross-functional environment.
• Innovative mindset and enthusiasm for leveraging technology in drug development