Associate Director, Clinical Science

Summary

Join Natera as an Associate Director, Clinical Science and lead the execution of clinical development objectives in oncology. This leadership role involves developing study concepts, leading protocol authoring, ensuring study manuals align with protocols, overseeing clinical data reviews, and representing clinical science in internal and external meetings. You will also develop clinical project timelines, support meetings and presentations, drive clinical research plans, build relationships with key opinion leaders, and ensure HIPAA/PHI compliance. The position requires a Ph.D./RN/MS or B.S. in a scientific field, 8-10+ years of clinical research experience (including 3-5+ years in management), and knowledge of regulations and GCPs. Oncology experience and experience with randomized controlled trials are preferred. The role offers a competitive salary and benefits package, including comprehensive medical, dental, vision, life and disability plans, free testing for employees and their families, fertility care benefits, and paid parental leave.

Requirements

• Ph.D./RN/MS or B.S. in a scientific field; advanced degree preferred (MS, Pharm D, MD, or PhD)
• 8-10+ years of clinical research experience, including 3-5+ years in a management role
• Experience with project management, clinical research, and scientific writing
• Knowledge of regulations and GCPs is required
• Periodic travel (~15-20; includes overnight domestic and international travel to study sites, conferences, and meetings)
• 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
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

Responsibilities

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria
• Integrate stakeholder feedback and lead protocol authoring; respond to health authority feedback
• 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
• 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
• Develop SOPs and analyze complex data
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

Preferred Qualifications

• Experience in oncology preferred
• Experience with randomized controlled trials preferred
• Experience with in-vitro diagnostics is a plus

Benefits

• 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!