SunnyvaleRecruiter
the smart solution for Sunnyvale jobs

Senior Clinical Research Scientist

Company: Pharmacyclics, an Abbvie Company
Location: Sunnyvale
Posted on: September 14, 2018

Job Description:

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
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. The Senior Clinical Research Scientist assists the cross-functional study team (SMT) addressing protocol questions, including preparation of clinical study protocols, patient informed consents, and other core documents which are central to clinical and scientific trial conduct. This position reports to a Clinical Science Project Lead.
Key Accountabilities/Core Job Responsibilities:

  • Assist the medical monitor with regular and ad-hoc data reviews and interpretation; prepare and present summaries/documentations of these reviews
  • 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
  • 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
  • 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 protocol deviation review
  • Assist Clinical Operations with developing the operational strategies for clinical research studies and development programs (e.g. PI selection, CRO selection, budgets)
  • As agreed with the medical monitor, manage trial-related committees such as Safety Review Committees, Steering Committee meetings as well as independent DMC meetings, and serve as the clinical representative on various project sub-teams
  • Assist with protocol and study conduct training of CRAs, study coordinators, and investigators
  • Assist with responding to regulatory questions as well as respond to site IRB or EC questions
  • 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).
  • Effectively collaborate with cross-functional internal groups and external partners, as well as work effectively with external key opinion leaders and investigators.
  • Ensures that the clinical elements of documents are of quality, accuracy and format and comply with laws, regulations, and corporate standards.
  • As agreed with the medical monitor, manage trial-related committees such as Safety Review Committees
  • Provide timely and regular updates to the Cross-Portfolio safety team
  • Travel: Up to 20%, primarily domestic
    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.
      Required Education:
      • BS/BA in Sciences/Pharmacy/Nursing (Master's or PhD is preferred).
        Required Experience:
        • Post Graduate training in a health-related field and/or equivalent experience is desirable.
        • Minimum of 3 years' industry or industry related experience including working on clinical trials.
        • Experience in analyzing, interpreting, and summarizing clinical trial data for internal and external audiences.

          Equal Opportunity Employer Minorities/Women/Veterans/Disabled

          Keywords: Pharmacyclics, an Abbvie Company, Sunnyvale , Senior Clinical Research Scientist, Healthcare , Sunnyvale, California

          Click here to apply!

          Didn't find what you're looking for? Search again!


          I'm looking for
          in category
          within


Other Healthcare Jobs


Home Health Aides - Drive for Lyft During Off Hours, Make up to $27/hr
Description: What is Lyft Lyft matches drivers with passengers who request rides through the Lyft smartphone app.Signing up to be a Lyft driver is the perfect opportunity for you to set your own schedule and be your (more...)
Company: Lyft
Location: Clayton
Posted on: 09/21/2018

Clinical RN - Electrophysiology Lab
Description: ABOUT MARIN GENERAL HOSPITAL: Come and be a part of our healing team at the award-winning Marin General Hospital Ranked in the top 3 of general hospitals in the country, we have made great strides (more...)
Company: Marin General Hospital
Location: Oakland
Posted on: 09/21/2018

Healthcare home office
Description: 23 year old consumer driven national benefits company with an A with the Better Business Bureau
Company: Health Options 16
Location: Roseville
Posted on: 09/21/2018


Operating Room Travel RN: Stockton, CA
Description: Tailored Healthcare Staffing is seeking
Company: Tailored Healthcare Staffing
Location: Stockton
Posted on: 09/21/2018

Occupational Therapist - Skilled - (OT)
Description: The Occupational Therapist facilitates the development
Company: Club Staffing
Location: Sacramento
Posted on: 09/21/2018

Clinical RN - Medical Unit
Description: Come and be a part of our healing team at the award-winning Marin General Hospital Ranked in the top 3 of general hospitals in the country, we have made great strides since returning to our roots as (more...)
Company: Marin General Hospital
Location: Oakland
Posted on: 09/21/2018

Clinical RN - NICU
Description: Come and be a part of our healing team at the award-winning Marin General Hospital Ranked in the top 3 of general hospitals in the country, we have made great strides since returning to our roots as (more...)
Company: Marin General Hospital
Location: Santa Rosa
Posted on: 09/21/2018

Clinical RN - ICU
Description: ABOUT MARIN GENERAL HOSPITAL: Come and be a part of our healing team at the award-winning Marin General Hospital Ranked in the top 3 of general hospitals in the country, we have made great strides since (more...)
Company: Marin General Hospital
Location: San Francisco
Posted on: 09/21/2018

Nursing Faculty - Sacramento
Description: US-CA-Sacramento Job ID 2018-100999 Institution Chamberlain College of Nursing Department Academics Employement Type Regular Full-Time FLSA Status Exempt Opportunity at a Glance Do you remember the professor (more...)
Company: Adtalem Global Education
Location: Sacramento
Posted on: 09/21/2018

Home Health Aides - Drive for Lyft During Off Hours, Make up to $27/hr
Description: What is Lyft Lyft matches drivers with passengers who request rides through the Lyft smartphone app.Signing up to be a Lyft driver is the perfect opportunity for you to set your own schedule and be your (more...)
Company: Lyft
Location: Newark
Posted on: 09/21/2018

Log In or Create An Account

Username:
Password:
 

Forgot password?


Find us on Facebook

Find us on LinkedIn

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds