Contract Clinical Program Manager
Clinical Operations | Berkeley, CA | Part Time and Contract
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, including two marketed drugs. Zelboraf™ (vemurafenib) was the first precision medicine to be approved for the treatment of BRAF-mutant metastatic melanoma; Turalio™ (pexidartinib) was the first FDA-approved therapy for tenosynovial giant cell tumor. 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.
The contract Clinical Program Manager (“CPM”) will be a key member of the Clinical Operations team
responsible for execution of an early phase oncology clinical trial of moderate complexity, including management of a full service CRO and other study vendors, as well as resolution of site and operational issues, with support from a Plexxikon in-house CRA and CTA.
The ideal candidate is an individual with strong experience in oncology clinical trials who is comfortable being the primary CRO contact for most aspects of study delivery. This is a part-time contract role requiring approximately 20 hours per week for 6 months. Work will be remote.
Responsibilities include, but are not limited to:
- Oversee CRO site monitoring/management to ensure quality deliverables and adherence to study operational plans, timelines, ICH/GCP, protocol requirements, and applicable SOPs
- Support the Plexxikon medical monitor with review of enrollment packets, emerging safety and efficacy data, and review of protocol deviations/site issues
- Provide written and verbal study updates to internal, CRO, and site study team members
- Contribute to relevant core study/program documentation for assigned and other studies, including authoring, review, or QC of clinical protocol, informed consent form, annual safety report, investigator’s brochure, clinical study report, etc.
- Create and/or review study operational plans (e.g., monitoring plan, project management plan, trial master file plan)
- Provide basic biometrics input to CRO, such as: participation in review of data management plan, statistical analysis plan, CRF shells, and edit check design specifications; data cleaning oversight; management of CRO delivery of TLFs, datasets and associated data deliverables
- Perform review of full service CRO and central laboratory vendor budget accruals, invoices, and scope changes/work order amendments for assigned clinical study
- Proactively identify and mitigate project risks, including novel challenges posed by COVID-19
- Work closely with other functions in the organization (medical science, clinical supplies, safety, medical writing, translational medicine, DMPK, QA, regulatory, legal, finance, project management, business development)
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree (advanced degree desirable) in nursing, life science, or related field with at least 6 years of relevant clinical trials work experience (and 2 or more years as project manager) at a site, CRO, or Sponsor (oncology experience strongly preferred; small molecule experience desirable)
- Fluent working understanding of relevant ICH guidance (e.g., E6 R2) and CFRs
- Proven track record showing excellent clinical project management skills
Ability to support clinical development beyond clinical operations—understand/apply basic concepts in biometrics, medical writing, drug safety, clinical science, document archival, etc.
Ability to lead multi-disciplinary study teams both internally & externally
- 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
Plexxikon is a Berkeley-based small business with approximately 65 employees, located just off interstate 80. We offer a chance to work with talented people in a collaborative environment. 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, applicants who require accommodation in the job application process may contact the careers email at www.plexxikon.com for assistance. For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.