AbbVie

Clinical Data Strategy and Operations Program Lead III

AbbVie$120K — $145K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in business, management information systems, computer science, life sciences or equivalent (Master's preferred).
  • 8+ years of experience in pharma/clinical research/data management/health care or 10+ years in project management.
  • In-depth understanding of clinical trial processes and associated technology.
  • Proven cross-functional leadership abilities and influence without authority.
  • Strong coaching and mentoring skills in a matrix environment.

Responsibilities

  • Align CDSO study teams with strategic objectives for successful delivery.
  • Act as the operational lead and point of contact for assigned programs.
  • Engage and connect with global teams to meet operational goals.
  • Utilize analytics and tools to optimize study execution and monitor progress.
  • Ensure compliance with regulations, GCPs, and quality standards.
  • Provide feedback on vendor oversight related to clinical operations.
  • Coach and mentor team members while contributing to their development.

Benefits

  • Comprehensive benefits package including paid time off (vacation, holidays, sick).
  • Medical, dental, and vision insurance.
  • 401(k) plan for eligible employees.
  • Participation in short-term incentive programs.
Full Job Description
Job Description

Purpose:

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy and Operations (CDSO).

Responsibilities:
  • Aligns CDSO study teams with program- and study-level strategies. Supports governance of assigned programs and studies, both within and outside CDSO. Assigned programs may include programs of any size or any complexity.
  • For assigned programs, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at both the program and study levels.
  • Interacts with and influences all levels of management and cross-functional team members to achieve program objectives. Represents DS in cross-functional forums and, if assigned, leadership meetings.
  • Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines of own, as well as studies managed by the team. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
  • Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. Coordinates and participates as the DS study owner in regulatory inspections and internal quality audits.
  • Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance.
  • Responsible for coaching and mentoring team members, as well as providing input into their development.
  • Leads CDSO and cross-functional innovation and process improvement initiatives.
  • If assigned, responsible for identifying training needs and standardizing and facilitating training solutions for DS roles. Conducts "lessons learned" across functions.
  • May include direct and/or indirect supervision of staff, as well as contract resources.


Qualifications
  • Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Master's preferred. PMP Certification or Lean Six Sigma Green Belt desired.
  • Must have 8+ years of pharma / clinical research / data management / health care experience or 10+ years of project management experience (and / or applicable work experience).
  • In-depth understanding of clinical trial processes and involved functional stakeholders, and clinical\ technology. Management of a clinical trial from initiation through to completion in a lead role is required.
  • Demonstrated performance as a cross-functional leader. Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrix environment. Demonstrated effective communication skills. Demonstrated effective analytical skills.


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 short-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.

Explore Job Opportunities

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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Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
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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