Associate Director, Clinical Program Management
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built a strong pipeline of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.
The Associate Director/Director, Clinical Program Management is to work as part of the Clinical Development team reporting to Vice President, Clinical Development and Technical Operations.
Responsibilities will involve managing all aspects of clinical operations for assigned project(s). This includes contributing to the operational leadership relative to the direction, planning and execution of clinical programs and the data collection activities; monitoring adherence to protocols; and interacting with various internal/external groups to facilitate clinical programs. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Oversees the implementation of the clinical development plan for all assigned clinical studies by managing the contracts, budget, timelines, resources, enrollment and site activities
- Develops and executes a strategy to ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals and are in compliance with all applicable regulations and company policies and procedures
- Accountable for the review of clinical study protocols, CRFs and other study related materials for all assigned clinical studies
- Develops and maintains effective working relationships and communications with internal team members and external partners including CROs and sites
- Responsible for the development of clinical operations SOPs, processes, guidelines and/or work instructions and accompanying templates
- Participates in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, ICH-GCP and regulations of regulatory authorities
- Maintains knowledge of regulations, guidelines, policies and practices for conducting clinical trials
- Coordinates cross functional efforts to improve clinical development
- Drives cross-functional clinical team meeting and track all associated activities
- Identifies issues that may impact the overall project plans and initiates contingency plans, as appropriate
- Assists in departmental resource planning, budgeting and timeline setting to meet the company goals
- Partners with other research and development groups to achieve deliverables
- Minimum of 30% travel for site visit and patient recruitment
- Other duties as assigned
- Bachelors or Master’s degree in a scientific discipline is required. Equivalent experience may be accepted.
- Minimum of 8-12 years clinical trial management industry experience with at least 3 years project management experience is required. Experience in oncology, immuno-oncology and CAR-T therapy is a plus.
- 2 years of managing CRO experience is a plus.
- Experience and understanding of ICH and GCP is required. Knowledge of GMP and GLP is preferred.
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Excellent written presentation and relationship management skills are required.
- Proven strong project management skills.
- Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio and PowerPoint
For the best fit, the candidate should be a fast learner who is detail-oriented and results-driven with outstanding organizational skills, and a team player with strong interpersonal and communications skills and capable of working collaboratively with colleagues. The candidate should be comfortable in a fast-paced environment, able to adjust workload based upon changing priorities and willing to take additional responsibilities outside of initial job description.
Please submit your resume or CV and cover letter to Jobscore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.
If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.