AbbVie

Program Lead II, Clinical Program Development

AbbVie$138K — $165K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in nursing or scientific field (or equivalent); Associate's degree/R.N. with relevant experience accepted.
  • 12+ years of Pharma-related or clinical research experience.
  • 10 years in clinical research with proven leadership in managing multiple studies globally.
  • Experience in risk management and decision-making critical for project success.
  • Strong communication skills with a focus on mentoring and people management.
  • Subject matter expert in ICH regulations and clinical operations compliance.
  • Broad experience across all clinical study phases (Phase I-III, IV).

Responsibilities

  • Serve as an integral member of the Integrated Evidence Strategy Team, maximizing asset and portfolio value.
  • Develop and execute the clinical operational strategy for clinical studies/programs.
  • Evaluate risks and strategic options in alignment with asset strategy and priorities.
  • Influence management and cross-functional teams to achieve program objectives.
  • Contribute to portfolio planning, including cost, resource, and timeline development.
  • Review and provide content for clinical and regulatory documents (INDs, NDAs, etc.).
  • Manage the external budget for clinical programs ranging from $20-200 million.

Benefits

  • Paid time off including vacation, holidays, and sick leave.
  • Medical, dental, and vision insurance coverage.
  • 401(k) retirement plan options for eligible employees.
  • Eligibility to participate in long-term incentive programs.
Full Job Description
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) Qualifications • 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). Additional Information 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 Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay 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/vision insurance and 401(k) to eligible employees. • This job is eligible to participate in our long-term incentive programs. 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 employee 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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

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AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

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Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ

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