Clinical Program Manager
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 precision medicine to be approved for the treatment of BRAF-mutant metastatic melanoma. 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 its collaborators.
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. The Clinical Program Manager (“CPM”) will be a critical member of the Clinical Operations team reporting to the Director of Clinical Operations.
The CPM will manage operational strategies for primarily oncology clinical trials of moderate complexity. The CPM will collaborate cross-functionally to ensure corporate goals and objectives are met. The CPM is expected to manage CROs, vendors, and site related issues, with supervision from the Director of Clinical Operations. The ideal candidate will be an individual with strong experience in oncology clinical trials, who is comfortable being responsible for managing all aspects of the assigned clinical trials.
Responsibilities include but are not limited to:
- Manage outsourced activities and approved budgets for clinical studies, such as CROs, vendors, bioanalytical labs, pharmacodynamic/biomarker labs, and site monitoring to ensure quality deliverables and adherence to study operational plans, timelines, ICH/GCP, protocol requirements, and applicable SOPs
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Manage ‘Plextension’ studies in late maintenance phase, for which full study management (site monitoring, data management, eTMF management, etc.) has been assumed from CROs.
- Contribute to relevant study documentation including clinical protocols, annual safety reports, clinical study reports, etc.
- Create and/or review study operational documents/plans (informed consent form, monitoring plan, data management plan, project management plan, etc.)
- Provide basic biometrics input to CRO, such as: participation in CRF and edit check design review; data cleaning oversight; management of CRO delivery of TLFs, datasets and associated data deliverables
- 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 functions in the organization (medical science, clinical supplies, medical writing, translational medicine, regulatory, legal, finance, research)
- Support Investigator-Sponsored trials with Plexxikon investigational medicinal products.
- Represent clinical operations in cross-functional initiatives and act on behalf of team, as assigned by management
- Domestic travel (approximately 5-10% of the time) for study team meetings and to clinical sites for co-monitoring may be required
- Mentor and develop junior clinical operations staff
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree required (advanced degree preferred) in nursing, life science, or related field
- At least 6 years of relevant clinical trials experience (and 2 or more years as project/program manager) at a site, CRO, or Sponsor (oncology experience preferred)
- Experience with and understanding of relevant ICH guidance (e.g., E6 R2) and CFRs
- Proven track record showing excellent clinical project management skills
- Solid vendor management skills, e.g. CRO, central laboratory, bioanalytical/PD laboratory
- 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)
- Ability to lead multi-disciplinary teams both internally & externally
- Must have demonstrated problem solving abilities and strong organizational skills
- Ability to write and manage team review of technical documents, such as protocols, protocol amendments, and informed consent forms
- Comfortable in a fast-paced small company environment that requires flexibility to adjusting workloads based upon changing priorities and willingness to be a team player in order to accomplish the common goal of the project, regardless of level or type of work
- 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.
As an equal opportunity employer, Plexxikon is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990. For more information about equal employment opportunity protections, visit the EEOC.
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