POSITION SUMMARY: The Associate Director, Clinical Science is a leadership role responsible for executing Natera’s clinical development objectives in oncology. This role involves leading clinical study activities, contributing to clinical strategy, and driving timely execution of research projects to deliver high-quality data. PRIMARY RESPONSIBILITIES: <ul> <li>Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria</li> <li>Integrate stakeholder feedback and lead protocol authoring; respond to health authority feedback</li> <li>Provide protocol training and contribute to CRF design</li> <li>Ensure study manuals align with protocol and engage investigators in study design</li> <li>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</li> <li>Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)</li> <li>Serve as a clinical science representative on internal and external meetings</li> <li>Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones</li> <li>Support meetings (advisory boards, etc.) and deliver presentations</li> <li>Drive clinical research plans, including company and investigator-initiated studies</li> <li>Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives </li> <li>Build relationships with KOLs, consortiums, and sites</li> <li>Develop SOPs and analyze complex data</li> <li>Ensure HIPAA/PHI compliance and maintain training requirements</li> <li>Perform other duties as assigned</li> </ul> QUALIFICATIONS: <ul> <li>Ph.D./RN/MS or B.S. in a scientific field; advanced degree preferred (MS, Pharm D, MD, or PhD)</li> <li>8-10+ years of clinical research experience, including 3-5+ years in a management role</li> <li>Experience in oncology preferred</li> <li>Experience with randomized controlled trials preferred</li> <li>Experience with project management, clinical research, and scientific writing</li> <li>Experience with in-vitro diagnostics is a plus</li> <li>Knowledge of regulations and GCPs is required</li> <li>Periodic travel (~15-20; includes overnight domestic and international travel to study sites, conferences, and meetings)</li> </ul> KNOWLEDGE, SKILLS, AND ABILITIES: <ul> <li>Problem-solving skills and a fast learner</li> <li>Strong communication (oral and written) and attention to detail</li> <li>Ability to work independently and collaboratively</li> <li>Analytical and creative thinking</li> <li>Familiarity with Google and Microsoft suites</li> <li>Desire to work in a dynamic environment</li> <li>Hands-on leadership and a strong work ethic</li> <li>Ability to apply business knowledge, exercise judgment, and escalate issues appropriately</li> <li>Strong project management, organizational, and interpersonal skills</li> <li>Adaptability, initiative, and team-building skills</li> <li>Conflict resolution and follow-through skills</li> <li>Results and goal-oriented</li> <li>Strategic and flexible thinking</li> </ul>    <div><div><div>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 &amp; depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.</div><div>Remote USA</div><div>$160,900—$210,000 USD</div></div></div><div>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 <a href="http://www.natera.com/">www.natera.com</a>. 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: <a href="https://www.natera.com/notice-of-data-collection-california-residents" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a> Please be advised that Natera will reach out to candidates with a @<a href="http://natera.com/" target="_blank">natera.com</a> 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: - <a href="https://www.bbb.org/article/tips/12261-bbb-tip-employment-scams" target="_blank">BBB announcement on job scams</a>  - <a href="https://www.fbi.gov/investigate/cyber" target="_blank">FBI Cyber Crime resource page</a> </div>

Natera

Similar Remote Jobs