Senior Manager, Clinical Supplies 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 .

Senior Manager, Global Clinical Supplies Management

Reports to:

Director or levels above

Supervises:

Senior Clinical Supplies Management Specialist or levels below

Position Summary

Provides functional leadership to the GCSM Department. Provides functional infrastructure, as well as depth and breadth of experience within functional area to support clinical drug supply labelling, packaging and distribution in support of clinical studies. Maximize efficient use of departmental resources and budget to meet study team responsibilities.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.

Key Duties / Responsibilities

Assures "Excellence in Implementation" in the supply of study medication for all Clinical Pharmacology and Clinical Research studies and drug distribution as needed. Manages functional responsibilities within agreed upon timeline and budgetary constraints.

• Oversee direct reports, ensuring Project Specialists are accurate and on time in regards to planning and completing study requirements in time for study start date.

• Maintain department schedule and study timelines

• Interact with Medical, Regulatory, CMC, Biostatistics, PK and QA groups on a regular basis to meet the needs of the clinical studies and GCSM.

• Ensure the necessary tools and processes for the planning and coordination of packaging, labelling, distribution, reconciliation and destruction of study drug supplies

• Providing long term vision of project schedule and workload balance, identifying and mitigating potential risks.

• Collaborates with senior management to develop continuous improvement methodology and use key performance indicators to drive and quantify cost optimization while maintaining customer quality and service.

• Identifies gaps within the department and develops plans to close as necessary (ie. Training, lean, capacity, headcount, external logistics support).

Manage all aspects of clinical study requirements and Clinical Packaging departmental activities.

-Effectively organizes and conducts meetings, and demonstrates facilitation and listening skills

-Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals

-Represent GCSM at CMC/Clinical meetings to update and forecast the status of projects

-Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans

-Protocol interpretation and breakdown

-Demonstrates planning, project management, negotiation and presentation skills

-Builds relationships with and acts as a key resource and escalation point for internal customers and suppliers.

-Develops and manages strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.

-Works globally within logistics as well as cross functionally with peers to develop consistent practices.

-Develops and promotes cGMP compliant systems that document and demonstrate control of drug supply life cycle.

-Working closely with Operations peers to manage the overall supply chain and ensure no interruptions in supply.

-Team Representation: Represent the CP dept. at team/R&D meetings to update and forecast the status of projects

-IVRS management, development and implementation activities.

Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs

-Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures

-Demonstrates a comprehensive understanding of the drug development process and requirements of IND/NDA submissions

Qualifications

Minimum Requirements

Bachelor's Degree, preferably in Science

At least 3-5 years of professional experience including management experience in the planning, procurement, packaging, labelling, and distribution of clinical drug supplies around the world.

• Utilizes superior communications skills to develop effective working relationships with peers, executives and customers to maximize efficiencies across the organization.

• Manages the professional development and productivity of all staff members to ensure proper goal alignment, training, professional development and project requirements are met.

• Personally coaches, and mentors direct reports and provides career development.

• Acts with a sense of urgency and purpose balanced with strategic intent.

• Reacting to change productively and handling other tasks as assigned.

• Anticipating problems, offering solutions and continuously improving the function of company.

• Supports Company mission, goals and objectives.

• Utilizes quality and performance metrics to ensure regulatory compliance.

• Responsible for the completion of deviation and corrective action closure and reporting.

• Gives effective presentations to departmental and interdepartmental groups

• Optimize project management processes and sell their position to get buy in from the staff.

• Tactfully manage change in a PR&D clinical supply environment.

• Identify & introduce new technology to improve department productivity and quality

• Perform Training & Presentations

• Trouble-shoot and make decisions daily.

• Manage and maintain all equipment and automation requirements.

• SOP creation, review and approval

Ability to travel up to 5% of time

Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

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
IC
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.