Pharmacyclics, LLC

Senior Scientist III, Translational Oncology, Clinical Biomarker Lead

Location
Sunnyvale, CA, United States
Posted
Oct 18, 2019
Ref
2852
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:

Responsible for conception and implementation of overall biomarker strategy and development plans to support early stage clinical programs in AbbVie's oncology pipeline and portfolio. Directs pharmacodynamics, mechanisms of action/resistance, patient selection, safety and other clinically relevant biomarker studies through external CRO and internal efforts. Collaborates closely with Discovery, Clinical Science, Data Science, Clinical Operation, and Regulatory Departments to deliver biomarker results/reports to internal stakeholders and external regulatory agencies. Ensures that overall budgets, schedules, and performance standards are attained.

Accountable for the operational execution of biomarker strategy in oncology clinical studies, in compliance with AbbVie's processes and regulatory requirements.

Key Accountabilities/Core Job Responsibilities:

  • Works in the Translational Oncology Department to develop, establish, and lead efforts aimed at exploring novel biomarkers with association to clinical endpoints in early stage oncology studies.
  • Leads cross-functional Translational Oncology Working Group to drive biomarker analyzes using a deep biological understanding of clinical genetics, cancer biology or immuno-oncology.
  • Undertakes cross-functional engagement with Clinical Science and Clinical Operations for implementation of biomarker assays in the clinic.
  • Manages relationships with external analytical labs, provide input into trial-specific agreements and perform technical assessment of labs involved in biomarker sample analysis. Coordinates between CRO Assay Development group and clinical team, when necessary .
  • Provides input on biomarker-related sections in clinical study-related and regulatory documents (such as Clinical protocol, INDs, IBs, etc.).
  • Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components.
  • Participates in reviews and provides recommendations for business development opportunities.
  • Ensures that biomarker samples selection, data transfer, analyzes and reporting are performed in accordance to the study protocol and in compliance with regulatory requirements.
  • Participates in drafting of clinical study-related and regulatory documents, such as INDs, ICFs, IBs, Clinical Study Reports, ad hoc analyses, etc.


Qualifications:

  • BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
  • Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development biomarker strategies.
  • Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
  • Ability to multitask and work within timelines.
  • Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
  • Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
  • Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
  • Proven record of success in leading clinical biomarker studies in Biopharmaceutical companies, preferentially in oncology settings.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled