Program Manager Clinical Drug Supply Management

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Clinical Supply Management (CSM) is a part of the Clinical Drug Supply Management (CDSM) organization within R&D Development Sciences. CSM is responsible for the management, planning, packaging, labeling, and distribution of investigational products and clinical trial materials to support all AbbVie Phase I to Phase IV studies, along with Investigator Initiated Studies and Compassionate Use situations. Forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.Purpose:

Program Manager Purpose:

Serves as a Senior Mentor and manager of Clinical Supply Project Managers (CSPMs). Responsible for the project management of key clinical supply chain activities at the protocol level for the most complex studies in AbbVie. Responsible for managing large cross functional initiatives to find creative solutions to complex AbbVie clinical supply issues.

Responsibilities:

•Provides supervision, guidance and mentoring to all CSPMs to increase individual competencies and overall efficiency and capacity.  Assist with study assignments providing for employee growth and development. May directly supervise exempt staff. As Senior Mentor in CDSM directly support new CSPMs until they are completely trained and qualified to work independently.

•Monitors the effectiveness of processes and quality of all project work completed by CSPMs. Anticipates project needs, continually searches for ways to improve project deliveries. Meets all department, divisional, and corporate training requirements.

•Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.

•Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.

•Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol. Develops protocol specific labeling compliant with applicable global regulations.

•Demonstrates leadership skills by driving for continuous improvement and encouraging and supporting collaboration across departments.  Represent CDSM Project Management on cross functional and global initiatives which require clinical drug supply expertise.

•Act as a department SME on a process or systems critical to CDSM. Address department related issues to these processes or systems and train CSPM colleagues as needed.  (Examples include: SharePoint, Temperature Excursion Management team and processes etc.)

•Act as a leader among CSPMs by providing input on department discussions and taking the lead in resolving ad hoc projects/challenges as they become apparent.

•Build and maintain positive working relationships with peers, co-workers, external partners and other functional areas e.g.  Clinical personnel, QA ( GMP and GCP), Affiliates, Regulatory Affairs, Commercial, Operations, Third Party Manufacturers, etc.

•Demonstrates a strong consistent display of team behavior by actively participating in project-related teams and is accountable for supply related component.

Qualifications

Qualifications:

•Education: Bachelor’s Degree required preferably in physical science, math, engineering or pharmacy.

•5-7+ years total experience in the Pharmaceutical Industry.

•Must have strong understanding of clinical development and global supply chain requirements (SME level) including clinical study and clinical supply processes.

•Competent in the application of standard business requirements (for example SOPs, Global Regulations, OEC,).Strong understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes.

•Experienced participant in and key contributor to cross functional initiatives. Must have demonstrated strong leadership competencies.

•Ability to work collaboratively across departments/functions and interact in a tactful, professional and effective manner.

•Ability to and experience in working effectively and professionally with external vendors or partners.

•Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.

•Strong problem solving and Project Management skills.

•Strong communication skills (both written and oral).

Key Leadership Competencies:

Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance

Learns fast, grasps the “essence” and can change course quickly where indicated

Raises the bar and is never satisfied with the status quo

Creates a learning environment, open to suggestions and experiments to drive the science in the field of interest

Embraces the ideas of others, nurtures innovation and manages innovation to reality

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.