healthcare
Posted May 5Director, Clinical Science
at Natera
United StatesRemote
Responsibilities
- Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
- Ensure study manuals align with protocol and engage investigators in study design
- Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
- Support meetings (advisory boards, etc) and deliver presentations
- Drive clinical research plans, including company and investigator-initiated studies
- Build relationships with KOLs, consortiums, and sites
- Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
- Ensure HIPAA/PHI compliance and maintain training requirements
- Perform other duties as assigned
Requirements
- Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership. PRIMARY RESPONSIBILITIES:
- Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
- experience in clinical development in oncology clinical trials
- Deep understanding and preferably
- experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection •
- Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
- Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research •
- Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately
- Ability to work independently and collaboratively
- Familiarity with Google and Microsoft suites
- Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
- Demonstrated success in working in a cross-functional environment
- Ability to use a computer, phone, and read materials
- Flexibility to work with colleagues in a global setting
- Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
Experience
- 10+ years of pharma/biotech industry
Benefits
- The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
- Remote USA $192,600 — $240,800 USD OUR OPPORTUNITY
- Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
- benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other
- benefits include pregnancy and baby bonding leave, 401k benefits, commuter
Contact
- For more information, visit www.natera.com .
- Link: https://www.natera.com/notice-of-data-collection-california-residents/
- Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY.
Additional details
- Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.
- The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners.
- The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines.
- Provide protocol training and contribute to CRF design
- Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
- Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
- Serve as a clinical science representative on internal and external meetings
- in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
- Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product