Director, Clinical and Translational Development

Summary

Join Natera as the Director, Clinical and Translational Development, leading and overseeing clinical trials and pre-clinical studies to advance therapeutic candidates. This role requires a proven track record of successfully advancing therapeutics through various development stages, deep knowledge of regulatory pathways, and experience managing clinical and pre-clinical research projects. You will lead the planning and execution of clinical trials, collaborate with cross-functional teams, and ensure compliance with regulatory standards. The position involves developing clinical documents, delivering presentations, managing budgets and timelines, and mentoring a high-performing team. The ideal candidate possesses an advanced degree in a life science field and at least 10 years of relevant industry experience. Remote work is available within the USA.

Requirements

• Advanced degree (Ph.D., MD, PharmD, or equivalent) in life sciences, biology, pharmacology, or a related discipline
• Minimum of 10 years of relevant industry experience in clinical and/or pre-clinical drug development
• Proven leadership in managing clinical trials and pre-clinical studies within a biotechnology or pharmaceutical company
• In-depth understanding of clinical trial design, execution, regulatory requirements, and compliance standards
• Experience interacting directly with regulatory bodies (FDA, EMA) and preparation of regulatory documentation
• Excellent organizational, communication, interpersonal, and leadership skills
• Strong analytical and problem-solving abilities with keen attention to detail
• Proven ability to manage complex projects, budgets, and timelines effectively

Responsibilities

• Lead the planning, execution, and oversight of clinical trials and pre-clinical research programs, ensuring alignment with strategic objectives and regulatory requirements
• Design and oversee implementation of clinical trial protocols, ensuring scientific rigor, regulatory compliance, and ethical standards
• Collaborate closely with biostatisticians to implement appropriate clinical trial designs, data analysis methodologies, and ensure robust statistical approaches
• Lead the development of critical clinical documents, including clinical development plans, target patient profiles, and site training materials
• Develop and deliver presentations and reports for internal and external stakeholders, including advisory boards, steering committees, and training materials
• Serve as the primary point of contact for clinical development programs, providing regular updates to senior leadership and external partners
• Collaborate with cross-functional teams including R&D, Regulatory, Medical Affairs, Quality Assurance, and external CROs to ensure seamless coordination and execution of development programs
• Develop and implement robust clinical and pre-clinical development strategies and study designs
• Oversee clinical trial management, including site selection, patient enrollment, monitoring, data analysis, and reporting
• Ensure compliance with applicable regulatory standards (e.g., FDA, EMA) and internal SOPs, and proactively manage risks associated with clinical and pre-clinical activities
• Lead interactions with regulatory agencies, preparing and reviewing submissions such as INDs, CTAs, and other regulatory filings
• Manage budgets, timelines, and resources effectively to achieve development milestones
• Mentor and manage a high-performing team, promoting a collaborative, innovative, and results-driven culture

Preferred Qualifications

• Experience in oncology, immuno-oncology, personalized cancer vaccines, or related precision medicine therapeutic areas
• Familiarity with biomarker-driven clinical trials and personalized therapeutic approaches
• Experience in leading cross-functional teams, including external academic collaborations and contract research organizations (CROs)

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program