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).
Please apply for a full job description and company details! All applicants are confidential.
Director Medical Clinical Operations
...
Senior Director, Clinical Operations
The Senior Director of Clinical Operations is a pivotal role within our organization, responsible for driving the management, oversight, and hands-on execution of Alumis’s clinical programs. Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according...
Director / Sr. Director, Clinical Operations
Managing CTMs to ensure timely execution of Phase 3 studies.Supervising study programs as well as participating in the preparation of study budgets and contract negotiations.Contributing to cross functional development of departmental policies.Overseeing vendors in conjunction with study managers.An...
Director of Clinical Operations (CCT/ALS)
The Director of Clinical Operations at Royal Ambulance is a highly motivated, engaging, and supportive leader passionate about pre-hospital and critical care. In this role, you'll improve operations by optimizing resource allocation, enhancing deployment strategies, and streamlining workflows betwee...
Associate Director, Clinical Business Operations (24113-R-615-CLIN)
As an Associate Director in Clinical Business Operations, you will be responsible for ensuring efficient and accurate clinical trial study cost reporting and forecasting, creating, reviewing, and monitoring clinical site and vendor contracts and budgets to ensure consistency and alignment across stu...
Director Clinical Operations
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. Director, Clinical Operations - ONCOLOGY. Contribute to the creation of internal Standard Operating Procedures (SOPs) and clinical work p...
Director of Clinical Operations
ACCESS Specialty Animal Hospital Los Angeles is seeking an experienced Director of Clinical Operations to join our growing team!. The Director of Clinical Operations is to fulfill the leadership role as an “owner” of the hospital’s success. The Director of Clinical Operations should ideally possess ...
Sr. Director, Clinical Operations Oversight
The Senior Director, Clinical Operations Oversight ensures clinical and operational program integrity and compliance with state and federal regulatory standards and accreditation standards. Reviews and analyzes regulations to determine the impact on plan clinical operations and identifies the need f...
Director Clinical Operations Rare Disease
Key Skills:</p><ul><li>Experience leading and managing complex global clinical development programs is required</li><li>Superior verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization</...
Director of Clinical Operations - Partnership Opportunity in Rehabilitation
Clinical Excellence: Ensure high-quality patient care delivery by maintaining clinical standards, implementing best practices, and facilitating staff training and development. Join a leading staffing agency in the job placement industry, PostJobMatches By WorkStaff USA, as we seek a dynamic and expe...