Head of Pharmacology
Structure Therapeutics
6 months ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Job Responsibilities:
- Expand and guide the clinical pharmacology group, including FTEs and external vendors, to address needs in a fast-paced environment.
- Provide guidance and oversight of clinical pharmacology strategy across the portfolio; advocate for model-informed drug development (MIDD) and build a culture of evidence-based decision-making.
- Manage the department budget.
- Collaborate with cross-functional colleagues and leadership to support strategic and scientific planning and execution.
- Oversee development and implementation of translational strategies.
- Oversee analysis and interpretation of PK/PD data from clinical studies; collaborate on nonclinical studies using appropriate quantitative methodologies.
- Oversee clinical pharmacology competitive intelligence analysis and interpretation.
- Supervise and/or mentor junior scientists; drive process improvement for efficiency and consistency; support employee career development.
- Interact with external collaborators, board of directors, investors, key opinion leaders, and vendors as appropriate.
- Author or oversee authorship of regulatory document sections, publications, and represent Clinical Pharmacology in regulatory interactions.
- Represent Clinical Pharmacology on due diligence teams upon management request.
- Build Clinical Pharmacology capability in China.
- Contribute to implementing Artificial Intelligence to support drug development.
- Other duties as assigned.
Qualifications:
- M.D., Ph.D. in Pharmaceutical Sciences/Pharmacokinetics (or related) or PharmD with a Clinical Pharmacology fellowship.
- 12+ years of industry experience in Clinical Pharmacology in a matrix environment on drug development teams.
- Proven ability to manage vendor performance and stakeholder relationships while making evidence-based decisions; strong analytical, regulatory, negotiation, and communication skills.
- Clinical Pharmacology leadership experience in strategic and scientific settings.
- Cross-functional leadership and supervisory experience.
- Clinical Pharmacology experience with small molecules and metabolism.
- In-depth knowledge of global regulatory requirements and guidelines for clinical pharmacology (FDA, EMA, ICH), including interpretation/application and experience with regulatory interactions and filings.
- Strong interpersonal, communication, negotiation, and cross-cultural collaboration skills; ability to present complex concepts clearly and make sound decisions under pressure.
Travel Required:
- Occasional travel to conferences and company-related activities (including travel to China).
- Expand and guide the clinical pharmacology group, including FTEs and external vendors, to address needs in a fast-paced environment.
- Provide guidance and oversight of clinical pharmacology strategy across the portfolio; advocate for model-informed drug development (MIDD) and build a culture of evidence-based decision-making.
- Manage the department budget.
- Collaborate with cross-functional colleagues and leadership to support strategic and scientific planning and execution.
- Oversee development and implementation of translational strategies.
- Oversee analysis and interpretation of PK/PD data from clinical studies; collaborate on nonclinical studies using appropriate quantitative methodologies.
- Oversee clinical pharmacology competitive intelligence analysis and interpretation.
- Supervise and/or mentor junior scientists; drive process improvement for efficiency and consistency; support employee career development.
- Interact with external collaborators, board of directors, investors, key opinion leaders, and vendors as appropriate.
- Author or oversee authorship of regulatory document sections, publications, and represent Clinical Pharmacology in regulatory interactions.
- Represent Clinical Pharmacology on due diligence teams upon management request.
- Build Clinical Pharmacology capability in China.
- Contribute to implementing Artificial Intelligence to support drug development.
- Other duties as assigned.
Qualifications:
- M.D., Ph.D. in Pharmaceutical Sciences/Pharmacokinetics (or related) or PharmD with a Clinical Pharmacology fellowship.
- 12+ years of industry experience in Clinical Pharmacology in a matrix environment on drug development teams.
- Proven ability to manage vendor performance and stakeholder relationships while making evidence-based decisions; strong analytical, regulatory, negotiation, and communication skills.
- Clinical Pharmacology leadership experience in strategic and scientific settings.
- Cross-functional leadership and supervisory experience.
- Clinical Pharmacology experience with small molecules and metabolism.
- In-depth knowledge of global regulatory requirements and guidelines for clinical pharmacology (FDA, EMA, ICH), including interpretation/application and experience with regulatory interactions and filings.
- Strong interpersonal, communication, negotiation, and cross-cultural collaboration skills; ability to present complex concepts clearly and make sound decisions under pressure.
Travel Required:
- Occasional travel to conferences and company-related activities (including travel to China).