- Provides strategic leadership and direction to the Therapeutic Area Clinical Study Leadership organization, a global organization operating clinical studies in 60+ countries supporting all therapeutic area specific asset interventional clinical studies.
- Establishes an appropriate framework and oversight including input into strategy, prioritization, reviews and decision making to maximize the probability of achieving the on time and on budget delivery of clinical programs which is an AbbVie top priority and a critical success factor in realizing the LRP. This position is accountable for the on-time and on-budget operational delivery of all of AbbVie's Therapeutic Area specific clinical trials with speed, quality and data integrity.
- Is accountable to inform and execute the specific Therapeutic Area strategy. Active participation in other therapeutic area specific leadership or governance forums as required.
- 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 specific portfolio strategy. Successful delivery requires establishing strong relationships working in partnership with key stakeholders across Development, R&D, and AbbVie. Seeks alignment within the organization in order to deliver outputs and achieve the overall strategy.
- Seeks to continually raise the bar for the operationalization of AbbVie specific therapeutic area study teams, driving both timeline and resource efficiency, partnering cross-functionally for shared learning across the portfolio
- Will seamlessly manage multiple and competing resource and product streams with a focus on financial health and delivering projects on or under budget. Able to reallocate resources with ease in the face of changing priorities while remaining focused on innovation and streamlining processes.
- Brings a "can-do" attitude while being able to respectfully challenge partners and be assertive when necessary around project timelines, finances, and scope; stretches Clinical Development Operations to deliver more, while also serving as a gatekeeper for new initiatives and studies when it comes to feasibility, regulatory issues, and prioritization within overall budget and resource constraints.
- Directly leads the Clinical Study Leadership, Therapeutic Area leaders and their teams for each specific TA. Ensures the recruitment and development of the right talent and therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talent within the Clinical Development Operations global organization; for building upon our One Clinical Dev Ops and One AbbVie culture.
- Develops and implements strategic vendor selection and management/oversight program for the wide range of vendors used in specific therapeutic area clinical development. Is accountable for resolving vendor issues that need to be addressed at the executive level.
- 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 across Clinical Development Operations practices, processes and performance to achieve World Class Clinical Execution while driving transformational change to take and keep AbbVie ahead of the competition.
- Bachelor's Degree or higher in a scientific discipline or previous experience working directly in a clinical research setting
- A minimum of 12 years of bio-pharmaceutical industry experience in a global pharma organization delivering medicines/therapies to a broad market across various therapeutic areas.
- Broad knowledge and track record of successfully managing clinical trial operations through all stages of the drug development lifecycle. Knows what can go wrong and how to proactively prepare for all possible outcomes.
- Direct experience in care clinical research across early and late stage programs
- Demonstrated high level of competency in the AbbVie leadership behaviors. Experience leading scaled global teams; managing and developing talent; leader of leaders who is able to engage, inspire and align large, diverse teams of seasoned professional.
- Big picture and strategic thinker -can formulate a vision of future state and lead the organization to build tactical plans to achieve this. Experience implementing large-scale change and process improvements relating to medical operations and/or clinical trials.
- 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
- Excellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvements
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
- Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
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Senior Director, Clinical Development Operations - San Francisco, United States - AbbVie, Inc
Description
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 at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job Description
The Sr.
Director, Clinical Study Leadership, Therapeutic Area, oversees a global organization accountable for the strategic and operational design and delivery of all Therapeutic Area clinical research pipeline programs around the world for AbbVie.
Will play a critical role in the leadership, evolution, development and representation of the broader therapeutic area specific portfolio.Responsibilities:
Significant Work Activities:
Additional Information
Applicable only to applicants
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