Pharmacyclics, LLC

Clinical Research Scientist

Location
Sunnyvale, CA, United States
Posted
Sep 13, 2018
Ref
2505
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us at http://www.pharmacyclics.com/

General Position Summary/Purpose:

This position is responsible in conjunction with the Medical Monitor for the scientific planning, monitoring and reporting of assigned clinical trials. This position is part of the SMT, and reports to the Clinical Science Project Lead.

Key Accountabilities/Core Job Responsibilities:

  • Design clinical studies in collaboration with the clinical study teams
  • Assist Clinical Operations with developing the operational strategies for clinical research studies and development programs (e.g. PI selection, CRO selection, budgets)
  • Ensure trial implementation according to the protocol
  • Support the medical monitor with review and contributions to trial-related documents such as the statistical analysis plan, the data management plan, the medical monitoring plan
  • Assist the medical monitor with regular and ad-hoc data reviews and interpretation; prepare and present summaries/documentations of these reviews
  • Collaborate with the medical monitor to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends
  • Assist the medical monitor with data-related and/or safety-related queries
  • As agreed with the medical monitor, manage trial-related committees such as Safety Review Committees
  • Support the medical monitor with the development of program-level documents, including but not limited to clinical protocols, clinical study reports, abstract and manuscripts, presentations, investigator brochures, and various other internal and external documents and communications as needed
  • Provide timely and regular updates to the Cross-Portfolio safety team
  • Travel: Up to 20%, primarily domestic
  • Assist in preparation of Clinical and/or Regulatory submissions (e.g. INDs, IND Annual Reports, Safety Updates, NDAs, CTDs, Investigator Brochure updates and protocol writing).
  • Other duties as assigned


Competencies:

  • Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment.
  • Capable of managing multiple priorities, and able to exercise sound judgment, work under pressure and produce accurate and timely work within a highly regulated environment.
  • Strong verbal and written communication skills a must, and ability to present scientific study data and results (clinical and non-clinical) to internal and external audiences required.
  • Strong organizational skills and an ability to take the initiative and be flexible in resolving problems as necessary.
  • An ability to interpret, discuss, and report trail / program level data effectively and identify trends is also required.


Education:

  • BS/BA in Sciences/Pharmacy/Nursing (Master's or PhD is a plus).


Experience:

  • Post Graduate training in a health-related field and/or equivalent experience is desirable.
  • Minimum of 3 years related industry experience including working with and supporting medical monitors and/or project safety teams.
  • Experience in analyzing, interpreting, and summarizing clinical trial data for internal and external audiences.
  • Previous experience as a field monitor


Equal Opportunity Employer Minorities/Women/Veterans/Disabled