Senior Clinical Trials Manager (Biotechnology/Oncology)

Role Summary

The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams. This role is accountable for planning and leading delivery of studies to time, quality, budget, and scientific requirements as outlined in the clinical study protocol. The SDL leads the Study Delivery Team and may oversee studies spanning early to late development across in-house, outsourced, and alliance delivery models. This role is onsite at Alameda, CA.

Responsibilities

• Accountable for the global study delivery strategy and overall study deliverables.
• Drive assessment, selection, engagement, management, and oversight of vendors.
• Ensure compliance with ICH/GCP guidelines, applicable laws, regulations, and SOPs.
• Make decisions balancing risk/benefit with impact on the study; mitigate risk as needed.
• Collaborate with matrix partners to develop and manage study-level budgets within project allocation.
• Prepare materials for internal governance and financial review cycles.
• Actively partner to build relationships with aligned staff in other functions and encourage perspective-sharing.
• Lead investigator meetings and study-related meetings; participate in governance meetings as necessary.
• Identify and communicate resource gaps for assigned studies.
• Lead risk management and quality efforts to ensure study compliance and inspection readiness.
• Lead or contribute to process improvement initiatives.
• Provide expert clinical operational input into protocol development.
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy.
• As the SDL, lead the SDT and collaborate with SDT members.
• Develop patient-centric documents and address patient burden.
• Engage Clinical Operations staff in process development, problem solving, and training initiatives as needed.
• Provide oversight of CRO and vendor performance.
• Support study-level status updates with focus on delivery to corporate and project objectives.

Qualifications

• BA/BS in biological sciences or related field with 9+ years of related experience; or MA/MS with 7+ years; or PhD/PharmD with 2+ years; or equivalent.
• Typically requires at least 9 years of life sciences experience, including 7 in clinical research and 4 in study management.
• Experience in starting up, maintaining, or close-out of studies; protocol development experience.
• Ability to provide clinical expertise to a development program; proficiency in complex study design.
• Experience preparing clinical sections of IND, BLA, or NDA; ability to communicate clearly on scientific and clinical issues.
• Experience managing multinational clinical trials and interactions with CROs/contract labs.
• Demonstrated matrix leadership, knowledge of regulations and guidelines, and strong organizational skills.
• Strong interpersonal, written, and oral communication; ability to work effectively in a matrix environment.

Skills

• Clinical trial management across various phases and delivery models.
• Vendor management and oversight.
• Regulatory knowledge (ICH/GCP) and adherence to SOPs.
• Risk management, quality assurance, and inspection readiness.
• Protocol development and data management collaboration.
• Effective communication and stakeholder engagement in a matrix organization.

Education

• As listed in Qualifications (BA/BS, MA/MS, or PhD/PharmD in biological sciences or related field).

Additional Requirements

• Travel may be required up to 20% in support of clinical study activities.