Director, Clinical and Translational Development

POSITION SUMMARY: 

We are seeking an experienced and dynamic leader for the role of Director, Clinical and Translational Development within our Therapeutics & Innovations Business Unit. Reporting directly to the head of the Therapeutics & Innovations division, this role will be responsible for leading, planning, and overseeing clinical trials, pre-clinical studies, and associated activities to advance our therapeutic candidates from discovery through clinical development.

The ideal candidate has significant experience managing clinical and pre-clinical research projects, deep knowledge of regulatory pathways, and a proven track record of successfully advancing therapeutics through various stages of development.

PRIMARY 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.

QUALIFICATIONS: 

• 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

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)
   

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$196,900—$246,100 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 prof