Early Clinical Development Operations Director
SpringWorks Therapeutics - Hybrid / Raleigh-Durham, NC
posted 4 days ago
About the position
The Early Clinical Development (ECD) Operations Director will oversee the operational aspects of clinical studies on both a portfolio and individual level and is responsible for all functional operations of ECD. As the operational lead for individual studies, the ECD Operations Director will serve as the primary point of contact for contract service providers (CSPs) involved in all study aspects and will independently work cross functionally for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. On a portfolio level, in collaboration with the head of Early Clinical Development/Clinical Pharmacology, the ECD Operations Director will support/execute the development of early development plans and strategy by sponsoring and/or leading key strategic ECD Operations organizational initiatives.
Responsibilities
- Lead key strategic ECD Operations' organizational initiatives, including the identification of process challenges, process enhancements, and training within the ECD Operations organization, if applicable.
- Lead study design, execution, and reporting of clinical pharmacology/proof-of-concept studies.
- Provide input into all phases of drug development including proof-of-concept, dose finding, dose optimization, exposure-response, and pediatric development.
- Lead development of clinical pharmacology sections for study design, protocol development, study execution, reporting, interpretation of data, regulatory filings including annual reports, investigator's brochure, and IND/NDA applications.
- Manage CSPs to execute clinical trials in accordance with contracted scope, costs, and timelines.
- Actively engage with CSPs on defining, monitoring, and reporting on aspects of key trial performance indicators.
- Author, review and/or manage a wide variety of activities, including clinical study synopses and study protocols, informed consent forms, case report forms, study reference manuals, monitoring plans, data management plans, site initiation visit meeting presentations, etc.
- Direct internal teams to ensure database lock activities occur in a timely manner.
- Coordinate activities for delivery of top-line data, as necessary, and review and approve clinical study reports in accordance with overall project timelines.
- Identify risks to clinical study execution success, proactively communicate risks to internal and CSP teams.
- Collaborate with internal and external scientific and medical experts to plan and execute studies that support and/or develop ECD strategies and plans.
- Develop or contribute to the development of SOPs, workflows and/or business practices.
- Oversee training requirements/compliance and financial forecasting for projects and staffing plans.
- Lead the creation, deployment, and management of ECD Operations' process and procedures, GCP compliance, and regulatory inspection-readiness activities.
- Perform other duties and responsibilities as assigned.
Requirements
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline required.
- 10+ years of experience in Clinical Research, with a focus on biotech and/or pharmaceutical Clinical Operations.
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations, particularly ICH and GCP.
- Demonstrated track record in conducting clinical trials in an out-sourced model.
- Experience participating in GCP inspection readiness as part of NDA/MAA activities with an emphasis in ECD.
- Ability to ensure optimal relationships with key internal stakeholders, as well as CSPs.
- Strong interpersonal communication skills to collaborate effectively in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
- This position must be able to work East Coast hours.
Benefits
- Discretionary annual bonus based on individual and Company performance.
- Relocation available.
