Head of Clinical Pharmacology

Structure Therapeutics•South San Francisco, CA

21h•$275,000 - $360,000

About The Position

Structure Therapeutics develops life‐changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. Position Summary: The Head of Clinical Pharmacology will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development and clinical development of pipeline molecules. The role will serve as a subject matter expert in DMPK, classical and quantitative clinical pharmacology and where appropriate, will contribute to translational approaches to streamline clinical development and define the optimal dose, route and regimen. Additionally, the position will be accountable for Clinical Pharmacology aspects of regulatory filings along with presentation of results and key messages to internal teams, executive management, health authorities and external collaborators.  The Head of Clinical Pharmacology will serve as a mentor to junior scientists, will have direct management responsibility and will be instrumental in helping build out Clinical Pharmacology capabilities at Structure Therapeutics in the US and China.

Requirements

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.

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.