structuretx

structuretx

Head of Clinical Pharmacology

South San Francisco, California

Sponsorship not specified$275k-$360kDetected 20 days ago
NegotiationProcess ImprovementClinical TrialsPharmacologyFDA RegulatoryAnimal StudiesLeadershipCommunicationCollaboration

About the role

  • 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.

Responsibilities

  • Advocate and build a culture of decision making with model informed drug development (MIDD)
  • Manage the department budget.
  • Oversight of the analysis and interpretation of PK/PD data from clinical studies, and collaborate on nonclinical studies, using appropriate quantitative methodologies.
  • Support employee career development.
  • As CP leader, author, or oversee authorship of, sections of regulatory documents, publications and represent the function at regulatory interactions, as appropriate.
  • Build Clinical Pharmacology capability in China.

Requirements

  • 12+ years of industry experience in Clinical Pharmacology working in a matrix environment on drug development teams.
  • 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
  • Travel Required:
  • If you are unsure if a message is from Structure Therapeutics, please email human resources.
  • M.D., Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or a related field or PharmD with a Clinical Pharmacology fellowship.
  • 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
  • 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.
  • Occasional travel to conferences and to company related activities (including travel to China)
  • Structure Therapeutics Inc. is an Equal-Opportunity Employer.
  • Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $275,000-$360,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience. At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
  • Notice to Recruiters/Staffing Agencies

Compensation

  • For this role, the anticipated base pay range is $275,000-$360,000.

Benefits

  • The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
  • Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

Company info

  • Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.
  • At Structure, base pay is only one part of your total compensation package.
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