Remotery

Executive Director, Clinical Science, Clinical Research Operations

Posted 6 hours ago

This is a fully remote position, open to applicants in California.

📋 Description

• Establish the strategic vision for clinical science and operational implementation within the endocrine clinical development portfolio.

• Foster collaboration among cross-functional teams to proactively identify and mitigate risks before they affect program schedules or quality.

• Assemble and nurture a high-performing team, which includes Clinical Scientists, consultants, and Clinical Research Project Coordinators.

• Manage clinical data oversight to ensure accuracy, thorough analysis, and proper interpretation.

• Propel the scientific execution by contributing to essential regulatory documents.

• Supervise strategic collaborations with Contract Research Organizations (CROs).

• Recognize, escalate, and facilitate the resolution of program and portfolio risks in a structured and timely manner.

• Promote ongoing enhancement and transformation initiatives within the Clinical Science team.


⛳️ Requirements

• Ph.D., Pharm.D., MPH, or MS in Biological Sciences, Life Sciences, Pharmacy, or a related discipline.

• Over 13 years of clinical research experience encompassing Phase 1–3 programs in a pharmaceutical or biotechnology setting.

• At least 6 years of experience in the Endocrine therapeutic area and in clinical development for rare diseases.

• Extensive knowledge of FDA and EMA regulatory requirements, Good Clinical Practice, ICH guidelines, and clinical drug development.

• Proven capability to translate operational realities into strategic decisions.

• Strong analytical skills and scientific acumen.

• Outstanding written and verbal communication abilities.

• A history of high-level performance in a dynamic, entrepreneurial biopharmaceutical environment.

• Demonstrated success in building high-performing teams and fostering talent development.


🏝️ Benefits

• Comprehensive health insurance plans for employees and their families, including medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays annually.

• Company-wide winter shutdown.

• Discretionary annual target bonus.

• Stock options available.

• Employee Stock Purchase Plan (ESPP).

• 401k matching contributions.

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