Associate Manager, Clinical Supply Management 8/27/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONAPPLY SPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
ESSENTIAL DUTIES AND JOB FUNCTIONS
The Associate Manager is responsible for:
- In depth understanding and application of principles, concepts, practices, and standards of Clinical Supply Management (CSM).
- Participates in cross-functional development project teams responsible for CSM.
- Manages outsourced manufacturing and distribution activities and related project logistics.
- Identifies new contractors, services and supplies necessary for the operation of materials and logistics organization.
- Reviews proposals and contracts. Negotiates prices, selects or recommends suppliers and analyzes trends.
- Ensures all regulatory requirements are met.
- Exercises independent judgment in developing new concepts, work processes, techniques and evaluation criteria for obtaining results.
- Strong negotiation, collaboration, verbal and written communication skills.
- Sound organizational and time management skills.
- Ability to effectively manage multiple priorities, strong project management skill.
The Assoc. Mgr. requires the following:
- Task management of contract manufacturers and depots is required.
- Leads and demonstrates independence in assigned therapeutic areas and development projects.
- Leads and works in projects with internal functional teams and external suppliers.
- Manage and support Clinical Supply Management activities (therapeutic/development) related to on-going and new clinical trials including Gilead-, Investigator-, and Collaborator-sponsored trials
- Work closely with Clinical staff to identify study-drug requirements and distribution warehouses
- Work with formulation, clinical packaging/labeling, and Quality Assurance to ensure adequate clinical supplies are manufactured and are available for trials
- Purchase comparator drugs following procure-to-pay process
- Manage domestic and international shipments of clinical drug products
- Ensure Gilead Standard Operating Procedures (SOPs) are followed at contractor facilities
- Apply import permit for international shipments and provide applicable documents to support import requirements
- Resolve shipping related issues in a timely manner
- Maintain accurate inventories at contract facilities/warehouses, resolve inventory discrepancies in a timely manner, and monitor expiring clinical drug products for disposal
- Review and if needed revise departmental SOPs to streamline and improve current practices
- Work on special projects, non-routine problems, ensure manufacturing schedules are met, and resolve technical problems
- Collaborate with functional peer group managers frequently
- Collaborate with senior management effectively
- Supervise, train, and guide staff (within department)
- Use ingenuity and creativity to develop solutions to moderately complex problems
- Manage multiple priorities effectively
KNOWLEDGE, EXPERIENCE AND SKILLS
- PharmD degree can be substituted for relevant experience
- 5 years or more relevant experience with MA/MS degree, or 7 years or more relevant experience with BA/BS degree,
- In-depth understanding (and application) of principles, concepts, practices, and standards of Materials & Logistics
- Working knowledge of current Good Manufacturing Practice (cGMP) and associated regulations
- Exceptional communication (written and verbal), strong negotiation, and sound organizational and time management skills
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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