Director of Clinical Operations
Clinical Operations | Berkeley, CA | Full Time
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s most advanced program, Zelboraf™ (vemurafenib) was the first oral targeted therapy to be approved for the treatment of both metastatic and unresectable melanomas. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and patients.
Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 70 employees based in Berkeley, California and the Director of Clinical Operations will manage the clinical operations team reporting directly to the VP, Oncology. The ideal candidate will be an individual with strong experience in managing oncology clinical trials, who is comfortable being responsible for managing all aspects of the team and assigning clinical trials.
Responsibilities include but are not limited to:
- Manage and mentor the internal clinical operations team
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Manage outsourced activities and approved budgets for clinical studies, such as CROs, vendors, bioanalytical labs, and site monitoring to ensure quality deliverables and adherence to study operational plans, timelines, ICH/GCP, protocol requirements, and applicable SOPs (work with finance department on study budgets and reconciliation)
- Assist with protocol design, medical issue resolution and assist with SOP development and GCP issues
- Contribute to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports
- Create and/or review study operational documents/plans (informed consent form, monitoring plan, data management plan, program management plan, etc.)
- Proactively identify project risks and propose risk mitigations with some supervision
- Participate in the selection of sites, CRO, and vendors
- Participate in study data review and other review activities as assigned
- Work closely with other teams in the organization and represent clinical operations in cross-functional initiatives and act on behalf of team, as assigned by management
- Identify program/resource gaps and propose solutions, including assisting the development team with potential staffing needs
- Up to 25% travel required to clinical sites for monitoring
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree required, advanced degree preferred with at least 10 years clinical operations experience within the oncology field (primarily with phase 1 and phase 2 trials, but phase 3 and NDA/BLA filing experience a plus)
- Experience in building, leading, and managing a clinical operation function within the context of a science-driven organization
- Must be well organized and able to provide senior operational support across multiple ongoing trials
- Experience with regulatory requirements relative to GCP’s, adverse event reporting, and knowledge of FDA regulations
- Advanced computer skills (e.g. MS Word, Excel, PowerPoint; MS Project)
- Proven track record showing excellent clinical project management skills including clinical supply logistics and managing to approved budgets
- Broad understanding of clinical operations in relation to clinical development functions
- Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
- Ability to effectively interface with medical personnel at clinical site(s) and also lead multi-disciplinary teams both internally & externally
- Ability to write technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Plexxikon, an equal opportunity employer, is located in Berkeley, just off interstate 80. We offer a chance to work with talented people in a collaborative environment and provide excellent benefits including health insurance, an annual performance bonus and long-term incentive program, generous time off and much more. To learn more about Plexxikon, please visit our website at www.plexxikon.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. 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.
Please no phone calls, agencies or recruiters