- 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 AbbVies 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.
Qualifications - Bachelors 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 improvementsSignificant Work Activities:
- 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 This is a remote opportunity.
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 Companybelievesingood faith it will pay for this role at the time of this posting based on the job grade for thisposition.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 the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays,sick),medical/dental/visioninsurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs 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 formofcompensation 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, consistentwithapplicable law. AbbVie 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.
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Senior Director, Clinical Development Operations - California, United States - AbbVie
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
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:
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