Clinical Affairs Scientist- Clinical Development

As part of the organization of the Chief Medical Officer (OCMO), our team partners very closely with many divisions within Agilent, and leading pharmaceutical companies, to develop manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.

We are searching for an experienced Clinical Affairs Scientist to work within the exciting field of oncology diagnostic devices. As a Clinical Affairs Scientist, your main responsibilities will be to determine clinical strategy in conjunction with team members, write clinical protocols, analyze data and write reports to support the clinical documentation of diagnostic devices in the field of tissue-based, and liquid biopsy, Cancer Diagnostics. This position requires support to regulatory applications and scientific marketing activities. The ideal candidate will have a strong working knowledge in biostatistics and oncology drug development, biomarker or in vitro diagnostic clinical development. The candidate will work directly with pharmaceutical partners, clinical and R&D scientists, Clinical Trial Managers and regulatory affairs to assure compliance with internal and external requirements.

Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.

Responsibilities include but are not limited to:

• Leads clinical projects requiring coordination with other functions, third parties
• Maintain responsibility for scientific content of clinical project deliverables including scientific design of studies, data analysis, and authoring of study protocols and reports for clinical development
• Contributes with cut-off determination, device bridging studies, risk analysis, study quality control and surveillance analysis in clinical trials
• Lead clinical strategic initiatives such as scoping and forecasting clinical efforts on upcoming projects and coordinating Medical Affairs and Clinical Affairs publication strategy
• Regularly interact with regulatory bodies, such as the FDA
• Develops and designs database and Data Report Forms.
• Write and interpret clinical protocols, reports and provide data analysis
• Responsible for the scientific validity of reported results and statistical analysis, tabulation and presentation of data
• Manages and oversees the governance, for internal and external stakeholders (Agilent and external laboratory sties, respectively).
• Interact and communicate with pharmaceutical partners, both domestic and international
• Solves a broad range of problems of varying scope and complexity
• Provide leadership and direction to the clinical affairs scientific staff
• Determine clinical strategy for Agilent’s in-vitro diagnostic devices
• Authors Clinical Investigations section in Premarket Approval Applications, specific sections in Instructions for Use (IFU) and authors Performance testing Clinical section in 510(k) submissions. Prepares, revises and maintains procedures for the conduct of studies
• Responsible for scientific content of medical and clinical project deliverables, including scientific design and authoring of study protocols and reports.

Qualifications

• Knowledge of clinical study design, biostatistics, and Good Clinical Practice.
• Master's Degree or Ph.D. (or equivalent terminal degree) in pharmaceutical, medical or other relevant biological science field. A Master's Degree in Business, or a Bachelor's Degree in Science, will also be considered with relevant experience.
• Experience working with external partners and/or regulatory bodies including the FDA.
• 4+ years of experience of industry experience in the fields of diagnostic, medical device and/or pharmaceutical products.
• Knowledge in oncology, companion diagnostic development, pathology, immunohistochemistry and/or next generation sequencing preferred.

The US pay range for this full-time position is $96,000.00 - $177,000.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at: https://careers.agilent.com/locations/americas/united-states/

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Option to Work Remote

Yes

Travel Required

Occasional

Shift

Day

Duration

No End Date

Job Function

Medical/Clinical