Clinical Development Operations Director: Strategic Leadership
4 days ago
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.
The company has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
Your RoleThe Clinical Development 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 Clinical Development Operations Director will serve as the primary point of contact for contract service providers 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 Clinical Development Operations Director will support/execute the development of early development plans and strategy by sponsoring and/or leading key strategic ECD Operations organizational initiatives.
Key Responsibilities- Lead key strategic ECD Operations' organizational initiatives, including the identification of process challenges, process enhancements, and training within in the ECD Operations organization, if applicable.
- Lead study design, execution, and reporting of clinical pharmacology/poof-of-concept studies. Provide input into all phases of drug development including, but not limited to 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 (e.g., country and site initiation activities, participant screening and randomization rates, and data collection activities).
- Author, review and/or manage a wide variety of activities, including for example, 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.
We are seeking a highly experienced Clinical Development Operations Director with:
- A 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 is required, 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, to enable the successful development and deployment of ECD and cross-functional development processes.
The expected salary range for this position is $167,250 - $220,000. A discretionary annual bonus may be available based on individual and Company performance. We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases.
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Durham, North Carolina, United States SpringWorks Therapeutics Full timeSpringWorks Therapeutics Clinical Operations Director RoleWe are seeking an experienced Clinical Operations Director to join our team at SpringWorks Therapeutics, a commercial-stage biopharmaceutical company focused on developing life-changing medicines for people with severe rare diseases and cancer.About the RoleThe Clinical Operations Director will be...
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