Director, Clinical Data Operations and Reporting, Oncology Early Development

4 weeks ago

South San Francisco, California, United States AbbVie Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

Purpose:

The Head of Clinical Data Operations and Reporting, Oncology Early Development, is a key role in the management and oversight of clinical data, statistical programing, subsequent analysis, ensuring transparency and sharing of trial data across AbbVie, and associated systems and vendors. This is a critical role to ensuring the highest quality clinical trial data is available to support company objectives for the early oncology pipeline. In this role, the primary focus will be on leading a team to provide quality oversight and ensuring proactive collaboration with our CRO partners and other external vendor partners. Similarly, it will be equally important to cultivate strong working relationships with various internal stakeholders across different departments.

Responsibilities:

Responsible for oversight and management of all clinical data operations, including data management and statistical programming related activities and deliverables, including vendor oversight, team leadership, oversight of systems (e.g., EDC, IRT).

Responsible for hiring, managing, and retaining strong statistical programming and data management team members.

Builds strong partnerships with internal and external colleagues to ensure data integrity, accurate reporting, and on time delivery of early phase oncology trials through proof of concept and/or advancement to late development.

Responsible for managing CROs and other outside vendors as appropriate in relation to clinical trial data acquisition/processing and analysis; set clear expectations for performance and align outcomes to meet AbbVie quality standards, relevant policies, and practices.

Oversees creation of and implementation of data transfer specifications from CRO to AbbVie to ensure internal transparency of data across AbbVie functions and teams

Responsible for managing CROs scope of work and internal oversight of CRO activities, ensuring quality deliverables and efficient implementation of outsourced work in statistical programming and data management including validation of accuracy of tables listings and figures delivered by vendors.

Defines and ensures implementation of a data management and statistical programming strategy in partnership with OED functions and translates that effectively to CROs for implementation. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency, and completeness.

Oversee data management and statistical programming tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution.

Manage small team of dedicated staff focused on partnering with and oversight of CROs; indirectly lead cross-functional working teams to partner with CROs in achieving outcomes and guiding seamless transition of work internally for programs that meet clinical proof of concept (cPOC).

Provides data management, statistical programing, clinical programming and other data-operations related activities oversight to outsourced clinical trails including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal review processes.

Proactively responds to the needs of other functions and influences appropriately to ensure the successful delivery of the portfolio in alignment with the broader Therapeutic Area portfolio strategy. Successful delivery requires establishing strong relationships working in partnership with key stakeholders across Development, R&D, and broader AbbVie teams. Seeks alignment within the organization to deliver outputs and achieve the overall strategy.

Brings a can-do attitude while being able to respectfully challenge partners and be assertive when necessary around project timelines, quality of deliverables, finances, and scope; actively monitors work to provide day to day guidance to external and internal partners; leads prioritization and planning with internal and external teams to ensure outcomes meet expectations.

Thrives in ambiguity and able to look at processes from an overarching viewpoint to see what can be optimized; prepared to drive that optimization.

Drives continual improvement and innovation initiatives with external partners, actively collaborates with AbbVie DSS colleagues to achieve World Class Clinical Execution while driving transformational change to take and keep AbbVie ahead of the competition.

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Qualifications

Qualifications:

A minimum of 10 years of statistical programming or data management experience in bio-pharmaceutical/biotech industry, preferably in an oncology therapeutic area. Ideal candidates will have 6-8 years of experience in statistical programming or oversight of statistical programming, preferably in processing and overseeing clinical trial data in the biotech/pharmaceutical industry.

BS/MS in biostatistics, computer science, information systems management, life sciences, business or related fields. 10+ years utilizing and/or administering clinical systems within the pharmaceutical industry or related area. 10+ years supervisory experience

Previous experience working directly in oncology trials across early and late stages of development is preferred.

Expert knowledge of clinical data management systems, statistical programming, operations systems, relational databases, and supported processes

Broad knowledge and track record of successfully managing clinical trial data through various stages of the drug development lifecycle through different sourcing strategies (e.g., insourced, CRO, IST). Knows what can go wrong and how to proactively prepare for all possible outcomes.

Ability to manage systems integration projects through strategic approaches that incorporate cross-functional business needs

Understanding of emerging requirements, regulations, and technologies and the possible impact to R&D

Strong leadership, problem solving, interpersonal and communication skills required for advancing the implementation, enhancement, and integration of technology and business processes, and for interactions across sites and with other functional areas

Excellent collaborator easily builds relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a highly matrixed organization.

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Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.To learn more, visit (US & Puerto Rico only)

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