Senior Manager of Clinical Supply

South San Francisco, CA

Contract

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OVERVIEW

  • We are currently searching for a skilled professional to join a well-known client’s team as Senior Manager, Clinical Supply. This role will play a key role in helping to set policy in a variety of organizational areas as the Company continues to evolve. The employee will work with the Development and Research Organizations to oversee the publication and promulgation of clinical and pre-clinical data as well as other important information. This position will have a strong outward facing presence and will support Investor Relations initiatives by representing the company in different capacities as required. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

RESPONSIBILITIES

  • Manage the storage, distribution and inventory tracking of unlabeled bulk product, labeled product, co-medication inventory and XX materials throughout the supply
  • chain at CMOs in the most cost effective manner and in compliance with cGMPs
  • Manage the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost effective and cGMP-compliant manner. Manage multiple vendor relationships, supply chain, distributions and return/destruction operations using IVR/IWR
  • Collaborate to develop Strategic Global plans with Regulatory Affairs, Quality and Clinical Operations professionals to ensure optimal drug supply, considering expiry dating and patient
  • activity for all sites in a Global Program
  • Schedule and implement labeling, packaging and Quality release operations with the CMO and multi-disciplinary team to ensure continuous clinical supply
  • Responsible to receive reports on excursions or deviations which may occur during shipment handling, and storage of drug products. Drive such investigations in collaboration with Quality,
  • CMO and clinical sites to resolution and define and implement procedures to minimize future such occurrences
  • Develop tracking systems to document the genealogy and detailed lot usage history of all drugs for each clinical trial
  • Working with CMO and CROs, manage the distribution and global Depot locations with special considerations on Import Licenses and shipping lead times for country specific requirements
  • Arrange for cost effective return/destruction of all product no longer suitable for clinical use

EXPERIENCE

  • Minimum of six years’ experience in GMP environment
  • Minimum of five years' Clinical Supply Management experience in biotech or pharmaceutical environment
  • Project Management skills in multidisciplinary environment with complex strategies and geographical specific requirements and ability to adapt to changes
  • Excellent organization skills, ability to lead multidisciplinary teams with excellent oral and written
  • communication skills
  • Experienced and successful at developing project budgets, tracking budget expenses, negotiation, SOX compliance and various financial operations

EDUCATION

  • Minimum of Bachelor’s degree in scientific or health related field

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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