Allergan Associate Director, Global Clinical Supplies in New Jersey
Associate Director, Global Clinical Supplies
New Jersey, United States at http://agn.referrals.selectminds.com/jobs/692/other-jobs-matching/location-only
▾ ▸ 1 additional location
Jersey City, New Jersey, United States
Oct 10, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Associate Director, Global Clinical Supplies providesfunctional leadership to the GCSM Department. Including functional infrastructure, as well as depth and breadth of experience in order to support clinical drug supply procurement and distribution in support of clinical studies. Maximize efficient use of departmental resources and budget to meet study team responsibilities. Responsible for coordinating the day-to-day professional operations of the department to ensure that clinical studies are adequately and seamlessly supplied with study medication throughout the duration of clinical trials.
Assures “Excellence in Implementation” in the supply of study medication for all Clinical Pharmacology and Clinical Research studies and drug distribution as needed. The GCSM department will be responsible for the coordination of drug acquisition, packaging, labeling and distribution in support of clinical drug supply for all clinical studies. Manages functional responsibilities within agreed upon timeline and budgetary constraints. Assures that all project deliverables (e.g. reports, data, etc.) meet quality standards, follow state and Federal regulations and are provided with excellence to appropriate departments and project teams.
Main Areas of Responsibilities
Manages the efficient flow of goods, services, and information needed to execute GCSM responsibilities which include, but are not limited to:
Manage all aspects of clinical study requirements and Clinical Packaging departmental activities.
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 timelines.
Interact with Medical, Regulatory, CMC, Biostatistics, Project Management, Finance, PK and QA groups on a regular basis to meet the needs of the clinical studies and PR&D.
Projection of study drug needs.
Procurement of study drug supplies.
Development and management of study budgets.
Coordination of packaging, labeling, distribution, reconciliation and destruction of study drug supplies.
Develop and implement a packaging, distribution, transportation and warehousing strategy, managed internally or through third party providers, such that costs and customer service are optimized.
Establishes and maintains packaging, distribution, transportation and warehouse budgetary goals negotiating with logistics suppliers to achieve the best cost and delivery possible.
Providing long term vision of project schedule, identifying and mitigating potential risks.
Monitoring and updating the resource levels needed to meet departmental and project objectives and relaying this data to other functional managers, including workforce planning.
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.
Develops and recommends process and system enhancements to improve operational efficiency, accuracy and customer service levels.
Identifies gaps within the department and develops plans to close as necessary (i.e. Training, lean, capacity, headcount, external logistics support).
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.
Completes position responsibilities by following established guidelines and protocols within the appropriate time frame.
Ensure clinical products are available at clinical sites for uninterrupted patient dosing.
Working closely with Operations peers to manage the overall supply chain and ensure no interruptions in supply.
Work with Formulators, Stability and Commercial groups in developmental packaging.
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.
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.
Adheres to established Company and department guidelines and protocols as well as Federal and state drug dispensing laws.
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 with minimal supervision.
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 and introduce new technology to improve department productivity and quality.
Trouble-shoot and make decisions on a daily basis.
SOP creation, review and approval.
Bachelor’s Degree, preferably in Science
At least 8 years of professional experience including management experience in the planning, procurement, packaging, labeling, and distribution of clinical drug supplies around the world.
Five or more years direct supervision of three or more employees.
Experienced and successful in discussing clinical drug therapies with research professionals.
Willingness and ability to follow SOPs and applicable regulations from CFR.
Knowledge cGMPs and relevant FDA Regulations essential.
Ability to uphold strict confidentiality of customer and employee records.
Excellent verbal, written, and listening communications skills.
Ability to exercise good, sound professional judgment and decision making.
Ability to effectively, tactfully and positively impact change when needed.
Proven teamwork and collaboration skills.
Deductive reasoning and analytical skills.
Demonstrated ability to balance objectives of high-quality with high-efficiency.
Demonstrates good skills in all forms of communication.
Ability to effectively negotiate.
Effective interpersonal skills.
Ability to adapt to change; flexibility.
Strong business planning, time management and organizational skills with the ability to multi-task.
Strategic mindset with a passion for execution and accomplishment.
Expects and drives for accountability.
Knowledgeable of departmental and industry best practices.