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AbbVie Program Manager, Investigator-Sponsored Trials (IST) and Collaborative Research (CR) in Sunnyvale, California

Program Manager, Investigator-Sponsored Trials (IST) and Collaborative Research (CR)

Requisition: 18-RHC-TM-0719

Location: Sunnyvale, CA

# of Openings: 1

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 athttp://www.pharmacyclics.com/

Pharmacyclics is seeking a

Program Manager, Investigator-Sponsored Trials (IST) and Collaborative Research (CR)

General Position Summary/Purpose:

Within the Medical Operations group, the Program Manager (PM) supports evidence generation within the investigator-sponsored trials (IST) and collaborative research (CR) program, by independently managing the trials from submission to study close out and all activities in between. The Program Manager works closely with internal cross-functional IST/CR Review Committee, external collaboration partners, and external investigators, including key opinion leaders. The Program Manager will be responsible for operationalizing key initiatives, tactically executing on deliverables and supporting the project management needs of the IST/CR programs.

Key Accountabilities/Core Job Responsibilities:

  • Develops independence with managing IST/CR Operations related systems and activities. Able to assess risk with complex tasks and elevate to manager for guidance as needed

  • Demonstrates subject matter expertise in IST/CR Operations related systems and functions. Able to assess existing policies and procedures and identify potential areas of risk or improvement and escalate to manager as needed. Able to identify impact of team activities to other functions and vice-versa and propose improvements/enhancements

  • Independently manages and facilitates the on-line activities associated with IST concept submissions, and the internal evaluation, reviews and approval/rejection process through the on-line application portal

  • Able to generate project plans, integrating team and cross-functional partner activities

  • Act as team lead for tracking progression of workstreams against project plan. Able to generate detailed reports and dashboards on project status

  • Demonstrates knowledge of core principles of change management. Able to implement core principles to team specific projects and effect transition/change

  • Demonstrates ability to effectively manage team & department contracts. Facilitates process from drafting through execution to ensure timely project initiation

  • Independently manage, track, and report on team spend and budget status against approved annual budget. Able to work with team lead as necessary to reallocate funds

  • Demonstrates basic knowledge of hematology-oncology, potentially focusing on priority histologies aligning with their IST/CR study management. Able to implement knowledge of core histologies to team specific projects and effect transition/change

  • Develops/possesses an understanding on the mechanisms of action, safety, and efficacy profile for the asset

  • Develops/possesses knowledge of the evolving treatment landscape across b-cell malignancies

  • Supports the preparation of IST/CR Working Group Meetings (Agenda/Meeting Materials) and may support with meeting facilitation and/or minutes

  • Execute on defined projects or tasks within the IST/CR group including, but not limited to: drug shipment, report generation, contract entry, protocol and informed consent review for standard template language and meeting coordination

  • Facilitate the on-line activities associated with IST/CR proposal submissions, and the internal evaluation, reviews and approval/rejection process through the on-line application portal

Qualifications:

  • Demonstrated experience in managing multiple projects

  • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results

  • Excellent organization and planning skills

  • Scientific and Medical terminology acumen

  • Strong interpersonal skills and communication skills (both written and oral)

  • Ability to problem solve and delegate appropriate tasks to others as needed

  • Knowledge of ICH/GCP guidelines and FDA regulations

  • Strong leadership skills, self-motivated, adaptable to a dynamic environment

  • Able to collaborate effectively with the study team, cross-functional team members, and external partners

· Proficiency in MS Outlook, Word, Excel and PowerPoint, database management

  • 2+ years project/program management experience in a pharmaceutical or biotechnology company

  • Experience in clinical research at either a hospital or pharmaceutical/biotech

  • Experience in project management a plus

  • BA/BS in a scientific discipline required

  • Advanced degree a plus

Abilities:

On a continuous basis, sit at desk for prolonged period of time at company facility to intermittently answer telephone, file, fax, or copy documents, and write or use a keyboard to communicate through written means. Walking and lifting up to 20 pounds may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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