Job Description


Director, Clinical Supply Management

Antiva Biosciences, Inc. is a privately held San Francisco Bay Area-based biopharmaceutical company focused on the development of antiviral therapies. The company is using a new medicinal chemistry platform to develop antiviral therapies, focusing first on HPV. Antiva has additional molecules that target HIV, the herpes virus, cytomegalovirus and others. Antiva’s lead compound, ABI-1968 is a topical antiviral for the treatment of human papillomavirus (HPV) infections, the primary cause of cervical and anal cancer. We are seeking an exceptional Director, Clinical Supply Management so direct all aspects of clinical supply and distribution. This includes strategic and operational leadership relative to the direction, planning, and execution of clinical trial material supply and distribution.

Summary

This role will be responsible for the labeling, packaging, storage, distribution, disposal, and final reconciliation of products across the Antiva development pipeline.

  • Develops and executes operational strategies, and collaborates cross-functionally to ensure corporate goals and objectives are met. 
  • Plans and implements activities related to the clinical material planning, material control, inventory control, and shipping/receiving and stores functions. Directs material schedules and coordinates the efficient movement of materials.

Responsibilities

  • Manages Antiva’s CROs for clinical packager/depots. Collaborates with Clinical Operations, Supply Management, Program Management, Regulatory Affairs, and Quality Assurance in the evaluation and selection of Antiva’s clinical packagers and distributors worldwide.  
  • Develops and maintains forecasts for clinical trial materials.  Supports design, development, implementation and maintenance of IXRS systems.
  • Works with Antiva team and vendors to define label content and text (i.e., English translated languages) for US and ROW clinical studies. Obtains approval for the labeling and packaging requirements for Antiva products for clinical development in the United States and other countries.  Implements the labeling and packaging requirements in a cost efficient and timely manner to ensure supply of released, packaged products for clinical use.
  • Ensures budgets, schedules and vendors performance requirements are met. Works closely with Accounting for timely review and approval of invoices. Works closely with Supply Management and with suppliers when invoices are disputed. Manages Purchase Orders and monitors supplier’s performance against each contract, including cost tracking for each PO/contract. Ensures each clinical packaging and distribution project is managed within budget. Coordinate the day-to-day fulfillment of drug shipment requests for all products under clinical development in Antiva in a cost effective manner and in compliance with cGMP requirements.
  • Collaborates with Antiva team to understand the product stability data and define acceptable practices and procedures for handling any excursions or deviations from recommended storage and handling conditions. Is the point person to receive the reports of any excursions or deviations which may occur during shipment, handling, and storage of products. Resolves such excursions or deviations in collaboration with Antiva Quality Assurance and defines and implements corrective/preventive actions to minimize the occurrence of such excursions or deviations.
  • Establishes and maintains a tracking system to document the genealogy and detailed usage history of all drug lots and for each clinical trial.
  • Develop forecast model for clinical studies support, and facilitate development of long term plan, including budget and supplies forecast

Requirements

  • The candidate should have good communication skills (oral and written), strong initiative, be highly motivated and ability to work in a fast-paced, dynamic environment.
  • A minimum of a Bachelors degree in a scientific discipline is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum of 12 years’ experience in the pharmaceutical or other related regulated industry is required. A thorough understanding of the FDA and cGMPs is required. A minimum of 5 years’ of clinical supply management experience is required. Must have a thorough knowledge of areas impacting Supply Management and the Supply Chain such as, Finance, Quality, Manufacturing, and Facilities.
  • Experience and familiarity with cGMP practices and knowledge of CFR, ICH, CDER guidelines for storage, handling, and distribution of drug products, experience with IVRS systems is required. Experience in frozen and refrigeration materials (cold chain management) is preferred.
  • Knowledgeable in global import/export requirements. Experience in successful management of relationships with contract service providers is required. Must be able to adhere to strict (or changing priority) project timelines and work independently with minimal supervision. The candidate must exhibit leadership skills with experience contributing to multi-disciplinary project teams.
  • Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task to be able to thrive in small company environment.
  • Ability to proactively identify challenges, possess strategic foresight and implement appropriate courses of action.

How to Apply

To apply, please mail or email your CV and cover letter to:

Antiva BioSciences, Inc.
Attn: Human Resources
6000 Shoreline Ct. Ste 203
South San Francisco, CA 94080
Email:

Antiva is an equal opportunity employer.