Job description
POSITION SUMMARY:
Natera is seeking a highly motivated and experienced Clinical Research Scientist to support both the development and execution of our innovative Oncology and Early Cancer Detection programs
The Senior Director/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 Senior Director/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 The Senior Director, Clinical Development will play a key role in the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biometrics, translational medicine, and program leadership.
PRIMARY 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
- Provide protocol training and contribute to CRF design
- Ensure study manuals align with protocol and engage investigators in study 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
- Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
- 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
- Support meetings (advisory boards, etc) and deliver presentations
- Drive clinical research plans, including company and investigator-initiated studies
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
- Build relationships with KOLs, consortiums, and sites
- 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
- As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
- Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
- Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
- Ensure HIPAA/PHI compliance and maintain training requirements
- Perform other duties as assigned
QUALIFICATIONS:
- Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
- Minimum of 12 years pharma/biotech industry experience in clinical development in oncology or early cancer detection clinical trials
- Experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection is preferred
- Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing 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
KNOWLEDGE, SKILLS, AND ABILITIES:
- Problem-solving skills and a fast learner
- Strong communication (oral and written) and attention to detail
- Ability to work independently and collaboratively
- Analytical and creative thinking
- Familiarity with Google and Microsoft suites
- Desire to work in a dynamic environment
- “Hands-on” leadership and a strong work ethic
- Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
- Strong project management, organizational, and interpersonal skills
- Adaptability, initiative, and team-building skills
- Demonstrated success in working in a cross-functional environment
- Successful and superior influencing skills across all levels of the organization and external collaborators
- Conflict resolution and follow-through skills
- Results and goal-oriented
- Strategic and flexible thinking
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. This may differ in other locations due to cost of labor considerations.
Remote USA
$185,600—$271,050 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. 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.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee 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 benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
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. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
