Associate Director, Clinical Operations
About The Position
N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how’ and transforming clinical trials through Prospective External Control Arms, better integration with clinical practice, and broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster. NPM is looking for an exceptional Associate Director, Clinical Operations with an appetite for hands-on development of clinical study management processes and study execution. As an Associate Director, Clinical Operations at NPM, you will collaborate closely with the Senior Director, Pharma Delivery Operations to play a pivotal role in establishing clinical study management necessary to drive NPM's critical applications in clinical trials and community oncology. You will work collaboratively with cross-functional teams, including Clinical Science, Compliance, Network Operations, Quantitative Science, and Pharma Delivery Operations to develop processes that support the efficient and effective conduct of clinical studies at our Network Partner sites, from planning to close out.
Requirements
- Bachelor's degree required; advanced degree in business, life sciences, or related field preferred
- 8 - 10 years of experience in clinical operations, delivery/program management, or client operations within biotechnology, healthcare, life sciences, or oncology clinical research
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CRF and ICH GCP
- Ability to manage multiple competing priorities and adapt to changes
- Strong communication, interpersonal, and problem solving skills
- Able to engage in strategic business discussions and craft executive-level communications and materials.
- Must be comfortable working in a fast-paced environment
Nice To Haves
- Experience working with EDC, CTMS, CTFM, and eTMF systems preferred
- Generous, Curious & Humble
Responsibilities
- Lead and oversee the strategic planning, implementation and execution of clinical trials and external control arms across multiple programs in accordance with project timelines, budget, and quality standards
- Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
- Collaborate cross functionally with internal teams, including Clinical Science, Compliance, Network Operations, Quantitative Science, and Pharma Delivery Operations to ensure alignment on clinical trial objectives and milestones
- Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program
- Serve as the point of contact for clinical suppliers, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
- Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
- Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Science, and Quantitative Science teams to ensure data accuracy and integrity
- Oversee the eTMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
- Oversee the development and execution of NPM’s biospecimen and imaging programs
- Contribution to the development of clinical trial management best practice processes and SOPs
- Hire, train and develop the Clinical Operations team, fostering a culture of collaboration, accountability, continuous improvement, and operational excellence
Benefits
- equity at hire
- discretionary annual bonus
- company benefits
- competitive industry benefits
- 401K plan
- other great company “perksâ€
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What This Job Offers
Job Type
Full-time
Career Level
Manager
