Director Of Clinical Operations

• Responsible for providing leadership to assigned Clinical Program(s) and teams/direct reports to ensure studies are led in accordance with the departments overall program goals, timeline, budget, and quality expectations.
• May develop and manage clinical budgets.
• Acts as a cross functional liaison and subject matter expert (SME) representing the clinical operations function, to ensure study plan aligns with business strategies necessary clinical operations scope input to proposals and work orders, with internal stakeholders.
• Allocates appropriate resources to projects and programs, and prepares, revises and maintains procedures for the conduct of studies. Develops contingency plans and risk mitigation for management of clinical studies.
• Responsible for ensuring clinical trials are conducted in compliance with the company’s procedures, FDA, regulations, Good Clinical Practice (GCP) requirements and any other applicable guidance and regulations.
• Ensure that clinical monitoring is being conducted in alignment with department SOPs, regulations, GCP guidelines and study-specific monitoring plans. And participates in development and maintenance of clinical monitoring SOPs, tools, and document templates. This may include making improvements to processes and procedures and/or implementing necessary improvements.
• May participate in partner governance meetings and business development processes to in support of relationship development and gross new business opportunities.
• Ensures quality, consistency, and guidance to the employee team on clinical operations and associated core deliverables including resource planning and coordination, monitoring, initiation/training, lab site, and management of Contract Research Organizations (CRO).
• Manages and holds accountable employees responsible for overall clinical study management, including planning, communication, coordination, and practical tasks for the studies. This includes selecting, developing, managing, and evaluating personnel to ensure efficient, collaborative, and robust clinical operations function.
• Oversees and participates in the selection of monitoring resources. And responsible for development, implementation, and oversight of novel monitoring approaches in compliance with company policies.
• Proactively provides portfolio updates, including oversight of trial status/metrics (key performance indicators (KPIs), budget, accomplishments and risks to senior management and other relevant stakeholders.
• May collaborate closely with relevant health care professionals and organizations while executing and supporting our clinical operations programs.

Qualifications

• Proven ability to work on multiple projects in a fast-paced environment.
• Strong ability to prioritize tasks and keen attention to detail.
• Bachelor’s degree required in a scientific discipline, Master’s Degree (M.S., M.A., MBA, etc.) or terminal degree preferred. Minimum of 8 years of industry experience (Pharma, IVD, Medical Device).
• Excellent writing, communication, and presentation skills.
• Expert knowledge of GCP and FDA regulations required.
• Demonstrated leadership and project management skills.
• At least 5 years at a senior manager or associate director level formally managing or leading people, teams across complex projects/programs.
• Strong interpersonal skills with the ability to interact effectively with all levels of within and outside the organization.

The US pay range for this full-time position is $143,760.00 - $265,058.00/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

25% of the Time

Shift

Day

Duration

No End Date

Job Function

Medical/Clinical