Head of Clinical Pharmacology

Job Responsibilities

• Expand and guide the clinical pharmacology group including FTEs and external vendors to address the team’s needs on a fast-paced environment.
• Guidance and oversight of the clinical pharmacology strategy across the portfolio.
• Advocate and build a culture of decision making with model informed drug development (MIDD).
• Manage the department budget.
• Interact with cross-functional colleagues and leadership within Structure Therapeutics and contribute to strategic and scientific planning and execution.
• Oversight of the development and implementation of translational strategies.
• Oversight of the analysis and interpretation of PK/PD data from clinical studies, and collaborate on nonclinical studies, using appropriate quantitative methodologies.
• Oversight of clinical pharmacology competitive intelligence analysis and interpretation.
• Supervise and/or mentor junior scientists and contribute to process improvement with an eye towards efficiency and consistency.
• Support employee career development.
• Interact with external collaborators, board of directors, investors, key opinion leaders and vendors, as appropriate.
• As CP leader, author, or oversee authorship of, sections of regulatory documents, publications and represent the function at regulatory interactions, as appropriate.
• Represent Clinical Pharmacology on due diligence teams upon management request.
• Build Clinical Pharmacology capability in China.
• Contribute to the implementation of Artificial Intelligence to support Drug Development.
• Other duties as assigned.

Qualifications

• M.D., Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or a related field or PharmD with a Clinical Pharmacology fellowship.
• 12+ years of industry experience in Clinical Pharmacology working in a matrix environment on drug development teams.
• Proven ability to manage vendor performance and stakeholder relationships while making evidence-based decisions in fast-paced, global clinical development environments, supported by strong analytical, regulatory, negotiation, and communication skills.
• Clinical Pharmacology leadership experience representing the function in both strategic and scientific team settings.
• Cross-functional leadership experience and supervisory experience.
• Clinical Pharmacology experience with small molecules and metabolism.
• In-depth knowledge of relevant global regulatory requirements and guidelines related to clinical pharmacology studies, including FDA, EMA, and ICH guidelines. Ability to interpret and apply these regulations effectively in a practical context.
• Experience with regulatory interactions and filings.
• Strong interpersonal, communication, negotiation, and cross-cultural collaboration skills, with the ability to build positive relationships, present complex concepts clearly, and make sound decisions under pressure.
• Travel Required: Occasional travel to conferences and to company related activities (including travel to China).