Director, Clinical Science

POSITION SUMMARY:

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. 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:

• 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 needed
• 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
• 10+ years of pharma/biotech industry 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

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

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%