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Director, Translational Medicine Planning and Strategy

Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: March 16, 2019

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: As a key member of the Translational Medicine (TM) Leadership Team, the Director of Translational Medicine Planning and Strategy will directly report to the Head of Translational Medicine and is responsible for the strategic planning to optimize TM organization infrastructure facing external and internal stakeholders, along with the management of Biomarker Operation team to drive TM efforts in clinical programs to ensure the appropriate collection, delivery, and analysis of bio-samples globally with the highest standards of quality, ethics, and regulatory requirements. The ideal candidate will accomplish these institutional milestones by providing leadership, oversight, strategic direction, and mentorship to a team of approximately 6 members. Key Accountabilities/Core Job Responsibilities:

  • Responsible for establishing a unified system to scenario planning, high level forecasting of timelines, assessment of program level feasibility, and approximation of budget and resources within TM
  • Working cross-functionally with internal and external stakeholders, responsible for high level biomarker operation decision making, risk identification and mitigation planning, ensuring escalation and resolution as appropriate
  • Chair relevant operational meetings, where applicable, involving internal or external stakeholders
  • Proactively escalate organizational issues and risks that significantly affect biomarker program timelines, budget, and/or quality
  • Responsible for leading the aligned identification and selection of biomarker vendors across programs with the appropriate Subject Matter Expert (SME), Quality and Procurement
  • Have broad understanding of the science and technology of projects and display technical skills and knowledge required. Actively educate other team members through knowledge sharing.
  • Drive setting of biomarker operational program goals and milestones and monitor progress of operational lead for alignment
  • Maintain an overview of status and issues, and proactively communicate progress, challenges or changes that may impact timelines to relevant stakeholders, including TM Biomarker Leads and Clinical Teams
  • Responsible for providing leadership and strategic direction for TM Biomarker Operation Team to implement and execute biomarker strategy globally in clinical programs
  • Utilize scientific and clinical expertise to deliver high level biomarker operation plans for multiple therapeutics areas
  • Manage relationships with external analytical labs, provide input into trial-specific agreements and assess service level commitments of labs involved in biomarker sample analysis
  • Coordinates between CRO Assay Development group and clinical team, when necessary.
  • Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components. Qualifications:
    • BS, MS, or PhD in Science or related fields (BS with 13+ yrs or equivalent experience, MS with 12+ yrs or equivalent experience, and Ph.D. with 10+ yrs or equivalent experience)
    • Demonstrate capability in leading initiatives focusing on departmental wide process improvements including development and execution of operation strategy
    • Proven track record of leading a team of > 5 senior biomarker operation managers in fast-paced clinical development setting to effectively maintain study timelines, biomarker budget forecasting, vendor management, contract execution and clinical protocol review
    • Capable of partnerships with external diagnostic labs to leverage emerging technologies
    • Ability to collaborate, lead, influence and motivate others is a must
    • Effective mentorship capacity through indirect or direct reporting structure is a must
    • Be able to distill complex issues and clearly articulate solutions
    • Ability to demonstrate effectiveness and growth in a fast-paced and dynamic environment.
    • Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.
    • Collaborates with multi- disciplinary experts to integrate scientific objectives into activities associated with development of therapeutics
    • Outstanding presentation and communication skills Equal Opportunity Employer Minorities/Women/Veterans/Disabled

      Keywords: Pharmacyclics, LLC, Sunnyvale , Director, Translational Medicine Planning and Strategy, Executive , Sunnyvale, California

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