Director, Clinical Science

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate study concepts, encompassing study design, assessment schedules, objectives/endpoints, and eligibility criteria.

• Collaborate across departments to create Protocol and ICF documents/amendments and present these at governance committee and early clinical development team meetings as necessary.

• Provide training on protocols and assist in the design of CRFs.

• Ensure that study manuals are consistent with the protocol and involve investigators in the study design process.

• Gather insights from key investigators on study design and methodologies to align with research objectives, and actively engage in pre-site selection discussions, site initiation visits, and investigator meetings to facilitate successful study execution.

• Contribute to and supervise real-time clinical data reviews (including CRO oversight when applicable).

• Act as a clinical science representative in internal and external meetings.

• Create clinical project execution timelines and provide updates to senior management to guarantee the timely achievement of program milestones.

• In partnership with Data Management, develop a Data Review Plan, monitor clinical data for specific trends, and ensure CRF design effectively supports data collection in line with the protocol in collaboration with Data Management/Programming.

• Assist in meetings (such as advisory boards) and deliver presentations.

• Lead clinical research strategies, including company and investigator-initiated studies.

• Interact effectively with senior members in other functional areas for strategic planning to optimize clinical development in alignment with corporate goals.

• Establish relationships with KOLs, consortiums, and research sites.

• Provide scientific insights into the design and execution of clinical trials, their delivery, clinical data review, data cleaning, interpretation of results, timely reporting, and necessary activities for product registration.

• Participate as appropriate in ongoing enhancements and development of team processes, structures, systems, tools, and other resources; mentor and guide less experienced Clinical Scientists as needed.

• Oversee one or more direct reports, including responsibilities for hiring, training, developing, and retaining talent on staff as required.

• Engage in competitive intelligence and/or other market or industry assessment activities and projects as appropriate.

• Maintain scientific and clinical expertise in the relevant therapeutic and disease areas of assignment.

• Ensure compliance with HIPAA/PHI regulations and uphold training requirements.

⛳️ Requirements

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or a similar scientific field) is preferred.

• Over 10 years of experience in the pharma/biotech industry focused on clinical development in oncology clinical trials.

• Profound understanding and ideally experience in oncology molecular diagnostics, oncology companion diagnostics, or early cancer detection.

• Experience in data review, data cleaning, managing, and interpreting clinical trial results as well as writing clinical trial protocols.

• Strong foundational knowledge of FDA and other major country regulations, along with detailed knowledge of Good Clinical Practice and other regulations governing clinical research.

• Experience in managing direct reports, ensuring that roles are performed in accordance with job descriptions and that appropriate training is conducted and maintained.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Pregnancy and baby bonding leave.

• 401k benefits.

• Commuter benefits.

• Generous employee referral program.