Foster City

POSITION SUMMARY 

The Associate Director, Clinical Development will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis, are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Associate Director, Clinical Development operates in collaboration with other functions including internal Safety and Clinical Operations teams.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for drafting key clinical trial and program-level documents in collaboration with Clinical Operations, Biostats, Medical Writing and the CROs.
• Responsible for clinical aspects of study startup, execution and close-out in close collaboration with Clinical Operations, Data Management and CRO.
• Supports the medical monitoring of efficacy and safety data received from the clinical trials.
• Responsible for the clinical aspects of data review and the Data Review Plan.
• Supports preparation of clinical summaries for drug applications.
• Supports preparation of scientific/medical questions from regulatory agencies.
• Leading development of clinical development plan including clinical study design and protocol development.
• Support the analysis and drafting of clinical trial and scientific publications.
• Supports the planning, conduct and follow-up of external clinical development- or study-related meetings.
• Responsible for clinical aspects of the TMF.
• Support the running and operational aspects of the Clinical Development team including meeting support, inspection readiness and organizational support.

QUALIFICATIONS

Education/Experience:

• MD or Bachelor’s Degree or advanced degree in a life sciences discipline.
• If not MD, PhD preferred.
• 5 years of experience in the pharmaceutical industry (Clinical Development) preferred.
• Experience in clinical trials with multidisciplinary trial teams.
• Experience in fully outsourced CRO models.
• Medical/scientific expertise appropriate to clinical program.
• Demonstrates ability to establish strong scientific partnership with key investigators.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.

Knowledge, Skills and Abilities:

• Demonstrates excellent scientific writing skills.
• Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret and report data effectively.
• Strong experience in clinical data review and interpretation.
• In-depth knowledge of drug development processes.
• Strong verbal and written communication.

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