Senior Director, Clinical Pharmacology and Pharmacometrics - South San Francisco, United States - Structure Therapeutics

Description

Job Description

POSITION SUMMARY

The Senior Director, Clinical Pharmacology and 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 Clinical Pharmacology and 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 and the role is based in South San Francisco. #LIRemote

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Represent clinical pharmacology and pharmacometrics within multidisciplinary teams and contribute to quantitative development programs and strong registrational packages.
• Responsible for clinical pharmacology trial design, data analysis and interpretation, with special focus on the assessment of intrinsic and extrinsic factors that can impact pharmacokinetics and pharmacodynamics.
• Play a key role in the assessment of exposure-response relationship and human dose prediction for clinical trials.
• Develop mathematical models to evaluate pharmacokinetics and pharmacodynamics, and to conduct simulations to support trial design, as well as to conduct meta-analysis when appropriate.
• Promote the use of pharmacometrics approaches to enhance decision making internally and through external presentations and collaborations.
• Collaborate cross-functionally within the Clinical organization and Research for the appropriate design of Phase I-III studies; contribute to the preparation of key documents including investigators brochures, clinical study protocols, study reports, and regulatory briefing documents.
• Contribute to clinical pharmacology and pharmacometrics components in regulatory submissions, respond to regulatory authorities' queries and represent the function at regulatory interactions, as appropriate.
• Represent Clinical Pharmacology 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.
• Ability to work 3-4 days/week in the evenings to work with colleagues in Shanghai.
• Other duties as assigned.

REQUIREMENTS

Education

• Advanced training with a doctoral degree such as MD, PharmD, or PhD in Pharmaceutical Sciences, Engineering, Mathematics, Statistics, Medicine or related fields.

Experience

• 10+ years of drug development experience in the biotech/pharma industry
• Experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models, including the use of software such as NONMEM, R, Monolix, SAS and Phoenix/Winonlin
• Clinical Pharmacology and Pharmacometrics leadership experience representing the function in scientific team settings.
• Experience with clinical pharmacology 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 in clinical pharmacology and application of quantitative methods in drug development
• Experience with cardiopulmonary, type 2 diabetes mellitus and obesity preferred.
• 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.
  

Travel

• Around 15% for conferences, with a potential to travel to office in China.

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.