Position Overview:
The role is responsible for leading and managing the design and execution of comprehensive Clinical Pharmacology strategies to meet both commercial and regulatory objectives across multiple functions. This individual will drive the development of pharmacokinetics (PK) and pharmacodynamics (PD) studies, generate new study proposals, and lead the implementation of these strategies. They will also proactively assess advances in clinical pharmacology, PK/PD, and regulatory requirements, identifying strengths, weaknesses, and opportunities, and adjusting strategies as needed. The role ensures alignment between scientific and business objectives, managing clinical pharmacology aspects of various projects.
Key Responsibilities:
- Oversee the design and strategy of Phase 1-4 clinical studies, serving as the primary representative for the project(s).
- Lead the execution of strategies, guide teams, and provide contextual data analysis and interpretation, including the explanation of mechanisms of action (MoA) and disease-specific data, and discussion of model results in the context of research objectives.
- Write regulatory documents such as protocols, study reports, population PK reports, exposure-response analysis reports, clinical trial applications (CTAs), and sections for investigator brochures and white papers.
- Lead clinical pharmacology and biopharmaceutics meetings and serve as the Clinical Pharmacology representative in cross-functional teams, such as Clinical Strategy Teams and Asset Development Teams.
- Direct small, cross-functional teams to present a unified clinical pharmacology stance to clinical, CMC, and regulatory teams.
- Publish scientific papers and present findings at national and international conferences, interacting with key opinion leaders (KOLs) and other external stakeholders.
- Conduct due diligence for potential business opportunities, summarizing findings and representing Clinical Pharmacology in business development teams.
- Act as the Clinical Pharmacology lead in regulatory meetings, representing the team and driving discussions.
Qualifications:
- PhD with 4+ years of relevant experience, PharmD with 6+ years of experience, or Master's with 12+ years of experience, or Bachelor's with 14+ years of experience in a related field (e.g., PK, PBPK, PK-PD, Pharmacometrics, Drug Metabolism/Transporters).
- Excellent interpersonal and communication skills, with the ability to interact with internal teams and external KOLs.
- Strong strategic thinking with an enterprise-wide perspective.
- Proven scientific and technical expertise in clinical pharmacology and related areas.
- Leadership Competencies:
- Drive business results while positioning the organization for long-term success.
- Resilient and persistent in advancing innovative ideas.
- Demonstrates courage and respect in decision-making and interactions.
- Connects diverse ideas and fosters creativity and innovation.
- Leads by influencing teams to achieve cross-functional alignment.
- Demonstrates full accountability, both when delegating and being delegated to.
