Associate Director, Clinical Operations

Position Summary:

As an Associate Director of Clinical Operations (AD Clin Ops) you will be accountable for leading, or providing oversight of, multiple studies through collaborative leadership within the Clinical Operations and cross functional teams. Hence you will be responsible for inspiring the study teams, contributing to problem-solving, creating right-size processes and serving as a point of escalation.  You will also work closely with our Investigators, CROs and vendor partners.

Ideal candidates will have experience leading 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 and other teams.

Responsibilities:

• Lead full life cycle of study conduct by contributing to operational strategies, and translating strategic decisions into operational implementation
• Contributor to molecule Product Team and standing member of the molecule Clinical Sub-Team
• Manage direct reports (Clinical Study Leaders and clinical operations support staff) to ensure their effective leadership of Study Execution Teams
• May serve as Clinical Study Leader as required
• As a member of the Clinical Operations Leadership Team, will conceive of, contribute to and roll-out departmental initiatives and ensure efficient department resourcing
• Help to develop standard practices and training guidelines within the department
• Proactively collaborate with cross functional departments to meet company objectives on time and within budget
• Identify risks to study timelines and propose mitigations and implement solutions with team and management support
• Ensure corporate goals are effectively communicated and operationalized within the internal and external study teams
• Participate in cross functional study meetings, Investigator Meetings, scientific conferences and 1:1 outreach to investigators
• Monitor study quality metrics, identify areas for improvement and work with the team to put action plans in place
• Serve as the point of escalation and/or primary CRO contact for study conduct; Ensure robust CRO and vendor Governance and oversight are in place and effective
• Ensure compliance with protocol, overall clinical objectives, and regulatory requirements
• Participate in or may lead preparation of study plans and documents
• Mentor junior clinical operations team members for career development
• Complete other responsibilities as needed and agreed upon

Qualifications:

• Bachelor’s degree or equivalent training and experience (i.e., technical degree)
• Experience leading studies in a fast-paced environment
• Success in CRO and vendor management
• Excellent communication skills and ability to achieve milestones in a team environment
• 8+ years clinical study experience with time at a sponsor company preferred