This position will oversee the clinical operations team responsible for execution of global clinical studies for product(s) in a related therapeutic area.
Principal Responsibilities and Duties:
Oversee the management of the Company's CROs, central laboratories, vendors and global clinical sites to enable smooth, timely study execution from study initiation to close out.
- Develop protocols which can be implemented by the CRO and ensure adherence to all documentation requirements and process.
- Set and manage well defined clinical project timelines and milestones with the CRO, VP, Clinical Development and executive team, escalating issues that may jeopardize timelines and deliverables.
- Work with VP, Clinical Operations and Finance to develop budgets, accruals and track the financial status against budget.
- Work with CROs to ensure that milestones and deliverables are well defined and achieved.
- Oversee study logistics and monitoring activities, including patient recruitment, screening and enrollment.
- Interact with active and potential clinical investigators.
- Manage study monitoring, leveraging partnerships with CROs and regional monitors as necessary.
- Organize/run meetings and teleconferences for clinical studies.
- Liaise with other functional areas, such as Regulatory Affairs and Clinical Supply Chain in order to accurately coordinate clinical study activity.
- Contribute to the writing and review of protocols, clinical study reports and clinical sections of the Investigator's Brochure, INDs/CTAs and BLAs/MAAs.
- Represent Clinical Operations on the Product Development Team
- Maintain up-to-date knowledge of clinical principles and theories of drug development and study design in relevant therapeutic areas
- In collaboration with other Coherus clinical staff and departments ensure the clinical studies are conducted in compliance with Federal, State and local regulations, Good Clinical Practice regulations and internal Standard Operating Procedures.
- May act as primary liaison with clinical teams of development partners on assigned studies/program.
- Develop Standard Operating Procedures (SOPs) and study-specific guidelines as needed.
- Organize work and resources for Clinical Operations department including outside partners as necessary to achieve clinical development and corporate goals.
Background and Experience:
- BS in life sciences
- 10+ years of experience of biotech/pharmaceutical experience, including managing CRO contracts and ongoing relationships.
- Must have experience performing both small Phase 1 studies and larger, global trial management.
- Experience in the execution of inflammation or oncology-related clinical trials preferred
- Familiarity with GCP and applicable FDA/EMEA regulations is required.
- Ability to prepare and present clinical trial updates to senior management.
- Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
- Ability to learn quickly, be flexible and apply new skills, procedures and approaches.
- Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision.
- Excellent organizational skills and the ability to apply superior attention to detail and organization skills in all aspects of work.
- Understanding of data management, statistics and medical writing processes.
- Ability to travel domestically and internationally. Some travel will take place on/over weekends.
- Strong computer skills, including all MS Office applications.