Pharmacyclics, LLC

Associate Director, Investigator Sponsored Trial & Collaborative Research Operations

Location
Sunnyvale, CA, United States
Posted
Dec 03, 2018
Ref
2549
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/

Associate Director, Investigator Sponsored Trial & Collaborative Research Operations

General Position Summary/Purpose:

The Associate Director of IST (Investigator Sponsored Trial)-Collaborative Research (CR) Operations is a leader within the Medical Affairs Operations organization who is responsible for the oversight and development of a team of technical professionals managing the totality of IST-CR trials from submission to study close out. This individual works closely and independently with internal cross-functional IST Review Committee, collaboration partners, and external investigators, including key opinion leaders (KOLs). Additionally, the Associate Director will liaise with and support the Director of Medical Affairs Operations in interfacing with CTEP (the operational arm of the NCI) and the NCTN's (National Clinical Trial Network) US cooperative groups as part of Pharmacyclics CRADA with NCI. The Associate Director liaises with KOLs, CTEP's Principal Investigators, and the US Cooperative Groups on phase I - III practice informing and standard-of-care changing studies. In partnership with Janssen, and within a highly matrixed team at Pharmacyclics, the Associate Director drives monthly group engagements strategically evaluating and operationally managing new submissions and existing IST-CR studies.

Key Accountabilities/Core Job Responsibilities:

  • Lead a team of IST-CR operations professionals in developing processes and advancing studies through start-up to closeout generating key signal finding and practice informing data for the asset
  • Oversight for the totality of the IST-CR generation operational activities including: proposal/protocol/ICF review, site coordination for study start-up activities, budget analysis for fair market value, and overall compliance operations
  • Co-leads the development and implementation of the IST-CR strategic priorities and evidence gaps in partnership with cross-functional colleagues at Pharmacyclics and Janssen
  • Drives the creation and implementation of the annual cooperative group strategy
  • Collaborate with the DALs (Disease Area Leads) in facilitating the review of new study proposals/protocols
  • Partners with Janssen in co-leading the monthly IST-CR Working Group meeting
  • Drives the annual IST-CR portfolio assessment resulting in the optimized operationalization of the study portfolio
  • Leads the review and updating of the CR compliance annual plan and for the quarterly monitoring of the IST-CR activities
  • Project manages and leads cross-functional teams leveraging innovative approaches in converting ISTs-CR studies into registrational trials
  • Conducts internally-facing presentations to cross-functional executive leadership forums
  • Partners with the HECOR-RWE lead to ensure real-world data generation needs and evidence gaps are addressed in the IST-CR strategy
  • Drives operational efficiencies by establishing process improvements, quickly identifying resolutions to issues, and developing communication plans to engage key stakeholders and increase IST-CR related communication across the organization
  • Manages IST-CR budget dedicated to IST-CR CTEP CRADA, and Cooperative Group Trials


Qualifications:

  • 5+ years of experience in the biopharmaceutical industry in Medical Affairs or Clinical Development/Operations
  • Minimum 3 years in supervisory role managing, motivating, and developing technical professionals
  • Established relationships and experience working with the NCI and/or NCTN (i.e US Cooperative Groups) is desirable
  • Demonstrated experience and track record for timely planning and execution of key initiatives, department priorities, and project coordination
  • Demonstrated ability and proficiency to work in teams and coordinate across multidisciplinary, nimble, and fast paced matrix teams
  • Possesses a sense of urgency; identifies and escalates challenges and problems and takes the initiative to propose solutions.
  • Demonstrated budget and resource management skills
  • Ability to build high level medical/scientific knowledge, and to grasp complex concepts quickly
  • Proven ability in establishing and maintaining cross-functional relationships with a wide range of internal and external stakeholders
  • Extensive working knowledge in hematology-oncology is preferred
  • Excellent written and oral communication skills including public presentations
  • Demonstrated budget and resource management skills
  • Travel 20-25%
  • Bachelor's Degree in Life Sciences or equivalent


Equal Opportunity Employer Minorities/Women/Veterans/Disabled