AbbVie

Director, Investigator Sponsored Trial & Collaborative Research Operations

Employer
AbbVie
Location
Sunnyvale, CA, United States
Posted
Nov 22, 2020
Ref
2007036
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Summary: The 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 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 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 Director drives monthly group engagements strategically evaluating and operationally managing new submissions and existing IST-CR studies.

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

Requirements:
  • 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%

Education:
  • Bachelor's Degree in Life Sciences or equivalent

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.