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Sr Clinical Trial Design & Development Manager

Remote:

Full Remote

Salary:

115 - 165K yearly

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Advanced degree in life sciences required (Ph.D. preferred), Experience in clinical trial design and management, Strong knowledge of regulatory requirements, Excellent project management skills.

Key responsabilities:

Design and oversee clinical trial protocols
Manage timelines, budgets, and cross-functional teams

Natera Large https://www.natera.com/

1001 - 5000 Employees

See more Natera offers

Job description

POSITION SUMMARY:

We are seeking a highly motivated and skilled Senior/Clinical Development Manager to support our innovative molecular therapeutics efforts. This role combines scientific expertise in clinical trials with robust program management skills to drive the development and execution of our clinical studies.

KEY RESPONSIBILITIES:

Clinical Trial Design and Oversight:
- Design clinical trial protocols.
- Oversee the implementation of clinical trials, ensuring they adhere to scientific standards, regulatory requirements, and ethical guidelines.
- Collaborate with biostatisticians to ensure appropriate data analysis methodologies are employed.
- Monitor trial progress, analyze interim results, and prepare reports for regulatory submissions.
- Contribute to core clinical documents: clinical development plan, target patient profile, site training materials.
Program Management:
- Develop and maintain a comprehensive program plan that encompasses all aspects of the clinical trial lifecycle from inception through completion.
- Coordinate cross-functional teams across clinical operations, regulatory affairs, and other departments to ensure alignment and effective execution of the program.
- Manage timelines, resources, and budgets to ensure project milestones are met on schedule and within budget.
- Identify risks and implement risk management strategies to mitigate potential impacts on the program.
- Develop content and reports for advisory boards, steering committees, internal and external training decks
Stakeholder Engagement:
- Serve as the primary point of contact for all program-related communications, including updates to senior management and external partners.
- Build and maintain relationships with clinical site teams, external CROs, and other stakeholders.
- Ensure transparent communication across all levels of the project team and stakeholders.
Regulatory Compliance:
- Ensure all clinical trial activities comply with regulatory standards and ethical practices.
- Prepare documentation and support regulatory submissions and interactions.
- Stay updated with changes in regulatory requirements and industry standards.

QUALIFICATIONS:

Advanced degree in a life sciences or related field (Ph.D. preferred).
Proven experience in clinical trial design and management, particularly in oncology or personalized medicine.
Strong understanding of regulatory requirements and clinical development stages.
Excellent project management skills with a proven track record of leading cross-functional teams.
Ability to communicate effectively with a variety of stakeholders including scientific and non-scientific audiences.
Detail-oriented with strong analytical and problem-solving skills.

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

$114,700—$164,900 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 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

Required profile

Experience

Level of experience: Senior (5-10 years)

Industry :

Biotech: Biology + Technology

Spoken language(s):

English

Check out the description to know which languages are mandatory.

Hard Skills

Regulatory Compliance Stakeholder Engagement Clinical Study Design Risk Management Cross-Functional Collaboration Data Analysis Oncology Project Management Personalized Medicine

Other Skills

Detail Oriented
Analytical Skills
Problem Solving

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