Director, Product Safety Team Program Management

BioSpace

$130K — $180K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • At least 7 years of healthcare industry experience with a strong grasp of drug development processes.
  • 9+ years of project management in cross-functional projects in a global setting.
  • Experience in at least two R&D areas such as clinical management, regulatory affairs, or drug safety.
  • Preferred experience in leadership and direct people management, driving change within teams.
  • Strong emotional intelligence and relationship management skills.
  • Familiarity with the intersection of regulations and pharmacovigilance.

Responsibilities

  • Lead the Product Safety Team Program Management function while providing strategic oversight.
  • Develop and implement project management vision and objectives within the PST.
  • Manage hiring, onboarding, and performance of Program Managers, fostering project management excellence.
  • Build partnerships with Patient Safety stakeholders to align program priorities with organizational goals.
  • Ensure adequate resources for Program Managers and creatively address resource challenges.
  • Account for the quality and timeliness of PST operations, addressing root causes of issues.
  • Prepare for audits and inspections, representing the PST PM team when needed.

Benefits

  • Comprehensive benefits package including medical/dental/vision insurance and 401(k).
  • Eligible for short-term and long-term incentive programs.
  • Paid time off for vacation, holidays, and sick leave.
Full Job Description
Job Details

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 www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

This position is accountable to the Office of the Product Safety Team (PST), within Strategic Operations under the Clinical Science organization. The Clinical Science and Patient Safety (PS) organizations work collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of our drugs to protect patients globally.

The Director, Product Safety Team Program Management, plays a critical role in defining and driving the strategic priorities of Patient Safety through exceptional strategic project management leadership across the PST. The PST is a high-profile, high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The PST partners with cross-functional stakeholders to devise innovative, safety-focused strategies aimed at optimizing the product benefit-risk profile for patients.

This role reports directly to the leader of the Product Safety Team Program Management organization and supports the leader with managing personnel, overseeing project management function within the PST, and executing strategic initiatives within the Office of the PST (OOPST).

Major Responsibilities:
  • Provides oversight, leadership, and strategic direction to the Product Safety Team Program Management function within the Product Safety Team (PST), and OOPST strategic initiatives.
  • Supports the development and implementation of the vision, strategy and objectives of the project management functions within the Product Safety Team (PST), and OOPST strategic initiatives.
  • Support responsibilities for hiring, coaching, training, onboarding, and managing the performance of PST Program Managers. Responsible for building and nurturing a culture of strong project management excellence across assigned PM teams.
  • Builds strong strategic partnerships with all Patient Safety stakeholders including Therapeutic Area Heads, PST Leads and other stakeholders (within and outside PS). Seeks their input to shape priorities for the program managers and leverages relationships to advance the goals of the team. Ensures successful partnership between the assigned program management functions, PST Operational Excellence teams and the PSTs.
  • Ensures that the assigned PMs are appropriately resourced. Collaborates with the Product Safety Team Program Management leader to plan and forecast the use of PST PMs across product safety teams. Seeks creative ways to utilize limited resources and works with Sr. Director Office of the PST to address critical resource needs
  • Responsible for achieving quality and timely metrics for PST and assigned teams. Collaborates with the Product Safety Team Program Management leader to understand root causes of quality and timeliness issues. Accountable for ensuring that root causes are addressed within the appropriate PM team.
  • Partners with the Product Safety Team Program Management leader to prepare for inspections and audits. Represents the PST PM team on audit and inspection teams, when required.
  • Promotes program management best practice and knowledge sharing across Product Safety Team Program Management functions and with other AbbVie program management teams.
  • Drives assigned critical OOPST leadership initiatives and projects that are critical to the success of the PSTs.
  • Manages Product Safety Teams as assigned. Represents the PST Lead and PST decisions in committees/meetings.
  • Supports and coaches PMs in addressing challenges that arise on the PSTs or other project teams, including navigating difficult decisions.


Qualifications
  • At least 7 years experience working in the healthcare industry and a strong understanding of the drug development process. Experience within Pharmacovigilance is desirable but not required
  • 9+ years hands-on project management experience in leading cross-functional projects within a global matrixed organization. Hands-on experience applying project management tools and templates
  • Required experience in at least two R&D areas such as clinical study management, regulatory, drug safety, discovery, etc.
  • Preferred leadership and people management experience. Experience in directly leading and driving major change initiatives within a team. Strong leadership presence and demonstrated ability in courageously challenging the status quo and influencing others. Experience in working directly with and influencing senior management including functional heads
  • High emotional Intelligence and strong relationship management and communication skills
  • Understanding of the connections between regulations and science for the benefit of drug safety
  • Understanding of tools, standards and approaches used to efficiently evaluate drug safety, is desirable but not required

Required Education:
  • Bachelors degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing [associates or equivalent] or healthcare profession, or biomedical disciplines)

Preferred Education:
  • Masters or advanced degree is desirable

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 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, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.
  • This job is eligible to participate in our long-term incentiveprograms


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 form ofcompensation 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, consistent withapplicable 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

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