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Clinical Pharmacology, Director/Sr. Director/VP

Status: Active
CompanyDenovo Biopharma
LocationSan Diego, CA
Expiration2023-05-16
How to Apply

Applicants who meet one of our vacant position designation criteria should send their resume to hr@denovobiopharma.com, indicating the position they are applying for in the subject heading. Candidates must be authorized to work in the U.S. Can work remotely.

Responsibilities:

  • Provide subject matter expertise in the design, conduct, and reporting of clinical trials
  • Lead clinical pharmacology studies and perform PK and PK/PD analyses
  • Preparation of standalone PK/PD section of Clinical Study Report (CSR), in NDA/BLA submissions
  • Present PK findings and represent clinical pharmacology in cross-functional study team settings, oversee CROs and external service providers, and management of Phase I-III studies
  • Interact with regulatory authorities to ensure the quality and supportiveness of pharmacology study data for regulatory agency review and inquiry

 

Skills:

  • Extensive and strong clinical pharmacology knowledges and research skills, including study design, data retrieval, problem solving and results analysis • Deeply understanding with relevant experience in PK/PD/ADME/BA for Phase I-III clinical studies.
  • Problem-solving skills and the ability to find and employ creative solutions
  • Time management and organizational skills, and attention to detail
  • Leadership experiences and the skills to manage and motivate others
  • Ability to translate pharmacokinetic findings into potential clinical impact is highly desirable
  • Related business development experience and capability is a significant plus.

 

Qualifications:

  • MD, PharmD or PhD degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics, or related scientific fields
  • Minimal 8 years working experience as a clinical pharmacologist in drug development for the pharmaceutical/biotech industry
  • A strong working knowledge of clinical pharmacology and related biological sciences
  • Work in a global operations mode in different time zones, able to travel on business needs

Please note these job descriptions are not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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