Job Title: Director, Clinical Operations - ONCOLOGY
Location: San Francisco Bay Area (2 days onsite per week)
The Director of Clinical Operations will lead and manage the assigned clinical operations team and play a key role in setting and executing departmental strategy.
Essential Functions and Responsibilities:
- Oversee clinical trial agreements, budgets, expenditures, and payments for clinical studies.
- Ensure the timely execution of clinical research programs and protocols from conception through final clinical study reports. This involves close supervision of external contract organizations responsible for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory functions, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities.
- Establish and maintain strong working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data, and adherence to study timelines.
- Maintain oversight of study conduct at study centers, including site selection, startup, monitoring adherence to protocols and GCP, applicable guidance, and study closure.
- Contribute significantly to the preparation and management of clinical study protocols and protocol amendments.
- Assist with the preparation of key documents such as Investigator Brochures, FDA Briefing Documents, and internal or external presentations.
- Contribute to the review of Investigator Sponsored Trials (ISTs) and relevant documentation to support these trials.
- Contribute to the creation of internal Standard Operating Procedures (SOPs) and clinical work practice documents, and implement these plans to ensure clinical operations align with regulatory requirements.
- Interface with senior medical staff and cross-functional team members, including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics.
- Provide direct supervision of Clinical Operations team members, including performance management and development planning.
- Represent the company at external meetings, scientific congresses, etc.
- Adhere to the company’s core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge:
- Bachelor’s Degree in health, life sciences, or a related field.
- At least 12 years of experience in pharmaceutical or biotech-related clinical research, with a focus on oncology.
- Demonstrated experience in leading phase 1-4 clinical trials and supporting Investigator-initiated trials.
- Proven success in managing clinical studies within timelines and budgets.
- Strong managerial skills and excellent interpersonal and communication (verbal and written) skills, with experience interacting with clinical monitors, investigators, and various internal groups.
- Ability to build strong relationships with peers and partners both within and across functional teams.
- Capacity to quickly assimilate information, identify critical factors and risks, and implement necessary changes.
- Proficiency in negotiation, influencing, and problem-solving to meet study timelines.
- High level of accountability and quality in deliverables.
- Proactive, self-directed, and adaptable in a rapidly changing environment.
- Open to others' ideas, promotes innovation, and manages goals effectively.
- Flexible and dynamic approach to working in a fast-paced biotechnology setting.
- Knowledge of PC operating systems and Microsoft Office applications (Word, Excel, PowerPoint, Project, Publisher, Outlook).
- Familiarity with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems (eClinical, Medidata RAVE, InForm), and Safety/Pharmacovigilance databases (ARGUS).
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