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 RD, 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)

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 www.natera.com.

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: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com 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:

- BBB announcement on job scams - FBI Cyber Crime resource page

Originally posted on Himalayas