Clinical Operations Associate Jobs in Berkeley, CA

ABOUT THE ROLE

The Associate Director, Clinical Operations will provide leadership and operational oversight of Clinical Operations activities to execute clinical studies in a manner that ensures milestones and company goals are met, and costs maintained within budget. This role will have program-level accountability for timeline, budget, quality, risk management, and ensuring compliance with Good Clinical Practice (GCP)

The position will work in a cross-functional environment with representatives from other involved functions and will oversee the activities of Clinical Research Organizations (CROs) and other vendors in the conduct and management of clinical studies. The successful candidate may eventually mentor junior staff in the set-up, maintenance, and close-out of clinical trials.

In this role, the Associate Director will be a key clinical operations leader supporting our MAR001program.  MAR001 is a a monoclonal antibody aiming to be the first biologic with a clean metabolic profile for the treatment of sHTG.  MAR001 has the potential to become best-in-disease and is rapidly progressing from phase 2to phase 3 clinical development.   This Associate Director position will be expected to drive execution across study start-up, vendor oversight, and delivery of high-quality late phase clinical data in a lipid disorders setting.

This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.

KEY RESPONSIBILITIES

Clinical Study Leadership

• Support program lead with setting and timely executing the development strategies for the clinical studies.
• Responsible for the strategic and operational oversight, management, execution, and delivery of the clinical studies for MAR001 and related clinical program activities.
• Lead the Study Management Team (SMT) for assigned clinical study.
• Resolve and/or escalate issues raised by the clinical operations team or the SMT.
• Ensure consistency between studies for assigned clinical program.

CRO and Vendor Management

• Support vendor selection, including request for proposals, leading bid defense meetings, critical review of contracts and negotiation of work orders.
• Oversee CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of the clinical program/studies and may co-lead operational governance meetings.
• Act as the main escalation point of contact for strategic CRO partner(s) for the assigned study and for the key stakeholders internally at Marea.

Study Planning, Risk Mitigation, and Enrollment

• Identification and oversight of potential challenges or risks with clinical study conduct and implementation of mitigation plans.
• Responsible for development and execution of clinical site engagement and subject recruitment strategies for assigned study.

Trial Design, Documentation, and Submissions Support

• Provide input and clinical operations perspective on clinical trial design.
• Author, provide input and/or oversee program level and study level documents to support clinical studies and regulatory submissions.

Budget, Resource Planning, and Operational Excellence

• Oversee financial aspects of assigned clinical study, including preparing related operating plans and ensuring adherence to planned study budgets.
• Oversee resource planning for assigned study to support Clinical Operations department head in overall departmental resource management.
• Support Clinical Operations department head with strategic initiatives and the implementation of those initiatives for process and operational improvements.

Inspection Readiness, Quality, and SOP Support

• Oversee/co-lead inspection readiness activities as it relates to clinical study execution and act as subject matter expert during regulatory inspections.
• Support Clinical Operations department on clinical SOP development.
• Support Clinical Operations department on ad hoc initiatives to leverage best practices as well as new technologies and applications for clinical study conduct.

• BA/BS or higher degree in a relevant scientific discipline required.
• Significant experience (10+ years) of clinical research / clinical operations and organizational management within the pharmaceutical industry; Biotech/small pharma experience preferred.
• Global clinical trial research experience preferred;
• Experience in phases 1-3 preferred; global phase 2-3 experience necessary
• Experience leading cross functional teams.
• Demonstrated ability to present complex information to management, vendors and external audiences.
• Demonstrated ability to create and manage one or more program budgets including communication of overspend/underspend.
• Demonstrated ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
• Strong attention to detail and the ability to establish priorities for the team.
• Demonstrated ability to work in a fast-paced environment with multiple competing tasks and demands, across multiple time zones.
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines and support Clinical Operations team in doing the same.
• Demonstrated ability to lead, motivate and mentor staff and teams.
• Excellent written and oral communication skills.
• High level of professionalism with internal and external stakeholders.
• Demonstrated ability to remove barriers to success.
• In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g., ICH-GCP).
• Previous line management or direct management of team members.

The salary range for this role is $190,000 - $210,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.