Associate Director, Clinical Pharmacology (Oncology TA) (Hybrid)

AbbVie • Waltham, MA

422d

About The Position

The Associate Director of Clinical Pharmacology in the Oncology Therapeutic Area is responsible for conceiving, executing, and managing multi-disciplinary Clinical Pharmacology development plans that align with commercial goals and regulatory requirements. This role involves leading Phase 1-4 study designs, authoring regulatory documents, and representing Clinical Pharmacology in various strategic meetings. The position requires a strong scientific background and the ability to critically evaluate and respond to advances in Clinical Pharmacology and regulatory landscapes.

Requirements

• PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field.
• Master's Degree or equivalent education with typically 12+ years of experience.
• Bachelor's Degree or equivalent education with typically 14+ years of experience.
• Experience with PK, PBPK, PK-PD, Pharmacometrics, or systems pharmacology.
• Excellent interpersonal skills and ability to lead teams.
• Strategic thinking and enterprise view.
• Proven scientific track record and technical skills.

Nice To Haves

• Experience in drug metabolism and transporters.
• Familiarity with regulatory submissions and interactions.

Responsibilities

• Conceive and execute Clinical Pharmacology development plans and strategies.
• Generate new PK/PD study proposals and lead those efforts.
• Critically evaluate Clinical Pharmacology, PK/PD, and regulatory advances.
• Accountable for Phase 1-4 studies design and clinical pharmacology strategy.
• Lead teams in data analyses and interpretation, providing necessary context.
• Author regulatory documents including protocols and study reports.
• Lead clinical pharmacology and biopharmaceutics meetings.
• Drive small teams to provide a unified clinical pharmacology position.
• Author scientific publications and present at conferences.
• Conduct due diligence assessments and represent Clinical Pharmacology on business development teams.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree