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Director Clinical Operations Analyst Jobs (NOW HIRING)

Immatics NV

Director, Clinical Operations Lead

Houston, TX · On-site

$215K - $260K/yr

The Director, Clinical Operations Lead will be responsible for the oversight, execution, and ... Strong analytical and problem-solving skills with the ability to assess operational impact across ...

Immatics NV

Director, Clinical Operations Lead

Houston, TX · On-site

$215K - $260K/yr

The Director, Clinical Operations Lead will be responsible for the oversight, execution, and ... Strong analytical and problem-solving skills with the ability to assess operational impact across ...

taiho

Sr. Director, Clinical Operations

Pleasanton, CA · Hybrid

Finally, the Senior Director, Clinical Operations will oversee implementation of all clinical trial ... Sound judgment and reasoning skills to define problems, collect and analyze data, establish facts ...

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Director, Clinical Operations

Director, Clinical Operations

Lyell Immunopharma

Seattle, WA • On-site

$200K - $240K/yr

Other

Re-posted 26 days ago

Job description

 

This role can be based out of either our South San Francisco, CA or Seattle, WA offices.  The incumbent will lead a program anticipated to grow to include multiple trials. This role will oversee the teams involved in the trials.

KEY ROLE AND RESPONSIBILITIES:
  • Leads the development of strategic planning for assigned clinical trial portfolio including timelines, budgets and resourcing (internal and external)
  • Oversight of operational feasibility; making decisions on recommendations and solutions to align with study and patient needs
  • Oversees study execution; manages risks in timeline, budget and quality, advises the team on actions to mitigate these risks
  • Ensures the cross-functional team is aligned with tactics and plans; addresses issues directly to resolve concerns
  • Leads the development of talent; ensuring coaching and performance management is conducted in a timely Guides leaders in talent management. Models the Lyell Leader Behaviors.
  • Supports TMF maintenance activities through timely filing of study and vendor documents as needed.
  • Oversees TMF quality by reviewing TMF health and works with CTM to develop mitigation strategies to ensure TMF issues are Escalates any TMF-related needs (vendors, systems) to senior leadership as needed, to support TMF health.
  • Develops the department; collaborates with VP Clinical Operations to ensure processes and procedures are in place as needed for the maturity of the
  • Effectively manages budgets and resources to meet goals and
PREFERRED EDUCATION:
  • BSc with a minimum of 17 years' experience
  • MSc with a minimum of 14 years' experience
PREFERRED EXPERIENCE:
  • A minimum of 8 years' experience in Oncology drug development and cell therapy experience
  • A minimum of 3 years' experience in early-stage drug programs
  • Proven experience in the design and development of clinical trial program
  • Prior experience with BLA submissions and regulatory authority inspections desirable
KNOWLEDGE, SKILLS AND ABILITIES:
  • Demonstrated knowledge of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
  • Proven ability to lead broad clinical operations teams and effectively lead cross-functional study execution teams
  • Has in depth understanding of FDA regulations and ICH GCP guidelines; successfully applied these to studies to drive effective, efficient and timely strategies
Lyell offers its employees a range of compensation and benefits. The salary range for this position is $200,000 to $240,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan. 
 
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
 
We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.

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