Reporting to the Senior Director of Clinical Operations, this position will be responsible for the operational direction and oversight of clinical studies, including timelines, budgets, cross-functional logistics and resources, as well as management of external contract organizations and functional services providers. The Sr CTM may be assigned to leading studies associated with a single molecule or may be assigned to studies associated with multiple molecules. The successful candidate must have good business acumen and some background in oncology, immuno-oncology, and/or metabolic diseases; someone who has demonstrated well-rounded experiences in clinical trial execution, preferably from study start-up to trial initiation, maintenance and closure.
- Actively provides direction and oversight of clinical trials
- Leads CRO and critical vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
- Supports the forecast and management of project/program budgets, including long range forecasting of clinical trial costs
- Develops and executes operational plans
- Provide technical expertise for the development of clinical documents (protocol, informed consent form, CRF, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.)
- Identifies clinical program/resource gaps and performs project risk analyses, and implements solutions
- Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
- Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
- Supports development of clinical operations quality systems, including standard operating procedures, document management, personnel training, and quality control processes
- BS required / MS, PharmD, or equivalent in a scientific discipline is preferred
- Minimum of 8 years of industry clinical operations experience with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing
- Oncology / immuno-oncology experience required
- Strong working knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials
- Experience in both US and Ex-ES clinical study management
- Direct and in-direct management experience
- Proven ability to provide highly organized and detail focused oversight to the execution of clinical studies
- Ability to succeed in fast-paced organization
- Demonstrated self-starter and team player with strong interpersonal skills
- Excellent written and verbal skills required.