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SENIOR DIRECTOR, CLINICAL OPERATIONS (CONTRACTOR)

This is a temporary contract position.  The Senior Director position is a leadership role within Gritstone’s Clinical Development Operations department. The primary role of the Senior Director is to oversee a clinical development program involving multiple clinical studies. The Senior Director will be responsible for the development of operational strategy, oversight of study team members, budget accountability, resource allocation, and ensuring operational excellence while complying with ICH/GCP guidelines.
The Senior Director will be responsible and accountable for:

  • Providing leadership, oversight and mentoring of clinical operations team members
  • Identify, evaluate and select optimal vendors
  • Oversight of vendors ensuring delivery of the clinical development program within timelines, budget and with high quality
  • Develop the clinical operational strategy and ensures its proper implementation
  • Accountable for the program’s timelines, budget and resource allocation
  • Contributes to the development of clinical documents
  • Contribute to the development of department processes and procedures
  • Ensure that clinical studies are operationalized in full compliance with SOPs, GCP, ICH and FDA guidelines
  • Oversee quality and risk management of the clinical development program
  • Oversees and ensures the proper implementation of clinical trial systems and workflows including IRT, EDC, central labs, central imaging, etc.
  • Oversee the proper implementation, and conduct of investigator meetings
  • Management of direct reports including performance reviews and career development
Minimum Education/Experience
  • Bachelor’s degree (or equivalent), preferably in scientific discipline or a health- related field.
  • 15+ years relevant industry experience, with at least 5 years of people management and leadership experience.
  • Demonstrated proficiency in implementing, monitoring and managing clinical studies, from study startup to study closeout.
  • Thorough knowledge of ICH/GCP guidelines and FDA regulations.
  • Previous experience with global oncology or immunotherapy clinical studies preferred.

Other Qualifications

  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment.
  • Self-motivated, self-disciplined and able to function independently as well as part of a team.
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills. 
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Gritstone bio anticipates that the hourly pay rate for this position could range between $115.00 and $154.00. Compensation will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered wage is also based on internal equity, internal position salary ranges, and market data. The wage range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Gritstone is a multistate employer and the salary offered will be market competitive. At Gritstone, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
Gritstone’s benefit package includes medical, dental, vision. Temporary Employees are also eligible to enroll in the 401k plan, which includes a 4% company match with immediate vesting. Employees are eligible to enroll in benefits effective the first day of employment. 
Gritstone bio is an Equal Opportunity employer, as such, recruiting is conducted in a fair and non-discriminatory manner without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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Contract, remote
DATE POSTED
August 15, 2024

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