Senior Director, Pharmacometrics

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 has completed an initial public offering (IPO) in February of 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.#LIRemote.

POSITION SUMMARY

The Senior Director, Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pipeline molecules. The position will contribute to translational approaches to streamline clinical development and define the optimal dose, route, and regimen. Additionally, the position will be accountable for the Pharmacometrics aspects of regulatory filings along with presentation of results and key messages to internal teams, executive management, health authorities and external collaborators.  The position will report to the VP, Clinical Pharmacology and Pharmacometrics.  

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Advocate for model informed drug development (MIDD) across drug discovery and development.
• Promote the use of MIDD approaches to enhance decision making internally and through external presentations and collaborations.
• Represent pharmacometrics within multidisciplinary teams and contribute to quantitative development programs and strong registrational packages.
• Strategic leadership in design (analysis plans), oversight, analysis and reporting of pharmacometrics analysis. May act as the author, reviewer and/or or approver of modeling and simulation analysis plans, outputs and reports.
• Develop mathematical models to evaluate pharmacokinetics and pharmacodynamics, conduct simulations to support trial design, including human dose prediction. Conduct model-based meta-analysis, when appropriate.
• Use artificial intelligence/machine learning, real word data, physiologically based pharmacokinetics, quantitative systems pharmacology, disease modeling or other tools for decision making, when appropriate
• Coordinate activities with contract vendors, consultants and pharmacometrics experts
• Contribute to pharmacometrics components in regulatory submissions, respond to regulatory authorities’ queries and represent the function at regulatory interactions, as appropriate.
• Represent pharmacometrics on due diligence teams upon management request.
• Create and contribute to the establishment of best practices for Clinical Pharmacology and Pharmacometrics activities - e.g. draft department work instructions, create protocol/report templates, training documents, and modeling and simulation infrastructure.
• Lead pharmacometrics deliverables associated to competitive intelligence efforts
• Other duties as assigned.

  

CORE COMPETENCIES, KNOWLEDGE, AND SKILL REQUIREMENTS

• Track record of effectively monitoring vendor performance, ensuring they meet contractual obligations, and taking corrective actions when necessary.
• Strong interpersonal skills to establish and maintain positive relationships with internal teams and external vendors, promoting collaboration and partnership.
• The ability to make informed, evidence-based decisions under pressure, weighing risks and benefits while considering the impact on the overall drug development strategy.
• The ability to think critically and analytically, evaluating information and data to make well-informed decisions.
• Sensitivity to and respect for cultural differences, especially when working in a diverse and global environment.
• Skill in negotiating and reaching consensus with stakeholders, including study sponsors, regulatory agencies, and internal teams.
• The ability to present complex scientific and clinical concepts in a clear and understandable manner, both in writing and verbally. This includes effective listening and providing constructive feedback.
• 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.
• Ability to work independently in a fast-paced environment and manage multiple deliverables.

REQUIREMENTS

Education

• Advanced training in Engineering, Mathematics, Statistics, Medicine or related fields.

 Experience

• 10+ years of drug development experience in the biotech/pharma industry

• Experience with dataset creation

• Application of pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric techniques (e.g. PopPK, PKPD, MBMA, statistical modeling), including the use of software’s such as NONMEM, R, Monolix, SAS, Matlab and Phoenix/Winonlin

• Pharmacometrics leadership experience representing the function in scientific team settings.

• Experience with pharmacometrics aspects related to the development of small molecules.

• Experience with regulatory filings (IND, NDA/BLA, MAA)

• Scientific excellence as demonstrated through track record of publications or presentations on pharmacometrics applied to drug development

• Experience with cardiopulmonary, type 2 diabetes mellitus and obesity preferred.

• Experience with PBPK and software’s such as Simcyp and GastroPlus preferred.

Travel

• Around 15% for conferences, with a potential to travel to office in China and one week a month to the SSF, CA office.

The target salary range for this full-time role is $246,000 - $295,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.