Program Lead II, Clinical Program Development (Director Level)

Regulatory Toolkit; Florham Park (NJ); In loco; USD 180.000 - 260.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off

Health/dental/vision insurance

401(k) plan

Long-term incentives

Descrizione del lavoro

AbbVie is seeking a Clinical Operations Program Director to connect science and operations across one or more clinical studies. You will lead strategic execution, manage budgets, and mentor a team of study managers and staff, ensuring regulatory and quality standards are met across global programs.

The role requires strong leadership, risk management, and the ability to influence cross-functional teams within Development Operations, with a focus on delivering high-impact clinical outcomes for

Competenze

• Bachelor’s degree or equivalent required; nursing or scientific field preferred.
• 12+ years pharma/clinical research experience.
• 10 years leading global clinical studies and driving study strategy.
• Experience in risk management and strategic execution is critical.
• Strong communication and mentoring skills; remote management preferred.

Mansioni

• Execute clinical studies/programs with timelines, enrollment options, and patient population considerations.
• Lead risk assessments and mitigations aligned with asset strategy.
• Influence multiple management levels to achieve program objectives across Development Operations.
• Manage budgets, resource projections, and timelines for development programs.
• Provide clinical operations content for regulatory documents (INDs, IBs, NDAs, BLAs, MAAs).

Conoscenze

Leadership

Strategic thinking

Risk management

People management

Communication

Remote management

Formazione

Bachelor's degree

Strumenti

none

Descrizione del lavoro

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

The Clinical Operations Program Director is responsible to connect science and operations to bring clinical studies to life through the execution of one or more clinical research programs .The Clinical Operations Program Director serves as a strategic advocate for pipeline assets and provides operational reality to our scientific experiments via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges. The Clinical Operations Program Director also serves as a inspiring people leader responsible for developing a pipeline of talent for the Development Operations organization.

Responsibilities

• Integral member of the Pipeline Commercialization Model’s Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee whose remit is to maximize the value of our assets and portfolio for patients and AbbVie.
• In alignment with the asset’s strategy and incorporating the science and the operations, develops the clinical operational strategy and is responsible for the execution of clinical studies/programs (e.g., generation of operational timelines, enrollment options, assessment of availability of the patient population, balancing complexity of trial designs vs speed)
• Responsible for the programmatic evaluation of risks and mitigations to achieving the asset strategy. Identifies strategic options for the Asset Strategy Team to evaluate in the face of competing priorities, interests or unanticipated challenges.
• Interacts with and influences all levels of management and cross-functional team members to achieve program objectives: primary scope of influence is within Development Operations, cross-functional colleagues who support clinical trial execution and the Development and Global Medical Affairs Therapeutic Area MDs/SDs.
• Key contributor to the portfolio planning process including responsibility for the development of the costs, resource projections and timelines for the clinical development programs under consideration.
• Reviews and provides clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books)
• Responsible for overall external budget management across their portfolio (programs can be 20-200 million dollars)
• Leads large scoped, cross-functional innovation and process improvement initiatives with significant business impacts and ensures effective change management across the cross-functional areas that support clinical program execution.
• Responsible for developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of 4 – 15 study manager(s) and up to 30 indirect staff, career development of clinical operations staff and creating an inclusive, innovative and learning environment where staff and studies/programs will succeed
• Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)

• Bachelor’s degree or equivalent is required, typically in nursing or scientific field. An Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
• Must have 12+ years of Pharma-related/ clinical research related experience (and/or applicable work experience)
• 10 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
• Experience in risk management, decision-making, strategic execution is critical to project and program success and ensuring pipeline decisions can be made on sound data.
• Possesses good communication skills.
• Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).
• Considered a subject matter expert in the application of standard business procedures (International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
• Integral participation in initiatives or advancement of strategies for clinical operations.
• Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase l-3, 4).

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local 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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein our long-term incentiveprograms.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html