Associate Director / Director Clinical Operations

Position Summary:

As an AD/Director of Clinical Operations, you will be accountable for leading, or providing oversight of multiple studies through collaborative leadership within the Clinical Operations and cross functional teams, conceiving of the operational strategy for that program, and ensuring delivery of high quality clinical trials on time and within budget.

Ideal candidates will have experience overseeing multiple studies within a clinical program and managing full service CRO partnerships. Your voice will be heard across CymaBay through collaboration with biometrics, medical safety, regulatory, QA and other teams.

Responsibilities:

• Bring innovation from the field into CymaBay Clinical Operations.
• Monitor study quality metrics and KPIs, identify areas for improvement and work with the team to put action plans in place.
• As a member of the Clinical Operations Leadership Team, conceive of, contribute to and roll-out departmental initiatives and
• Lead full life cycle of study conduct by conceiving of operational strategies and translating strategic decisions into operational implementation.
• Contribute to molecule Product Team and standing member of the molecule Clinical Sub-Team.
• Identify risks to study timelines and propose mitigations and implement solutions with team and executive management support.
• Ensure compliance with protocol, overall clinical objectives, and regulatory requirements.
• Develop processes related to inspection readiness and coach study teams to work with a spirit of high quality and inspection readiness.
• Mentor junior Clinical Operations team members in their career development
• Complete other responsibilities as needed and agreed upon.
• Help to develop standard practices and training guidelines within the department.
• Participate in cross functional study meetings as needed, Investigator Meetings, scientific conferences and 1:1 outreach to investigators.

Qualifications:

• Experience in line management of Clinical Operations team members
• Experience overseeing studies in a fast-paced environment
• Bachelor’s degree or equivalent training and experience (i.e., technical degree)
• Excellent communication skills and ability to achieve milestones in a team environment
• Strong program-level fiscal management and able to contribute to departmental budget
• 8+ years (AD) or 12+ years (Director) clinical study experience with time at a Sponsor company preferred
• Success in CRO and vendor oversight and governance
• Experience in building and coaching high performing Clinical Operations teams

The anticipated salary range for Associate Director candidates who will work in Newark, California is $175,000 - $195,000 and for Director candidates is $210,000 - $225,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.

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