Associate Director, Supply Planning

Supply Chain Waltham, Massachusetts


Description

Position Summary:

The Associate Director, Supply Planning will be a key contributor in the development and management of clinical trial and commercial demand plans. As part of the evolving Supply Chain department, this position will support converting clinical protocols and key planning parameters into robust forecasts and predictions for the planned use of clinical supplies. This position is accountable for the development, maintenance and communication of clinical trial supplies demand forecasts. This position will enable supply operations to maintain visibility to dynamic clinical trial requirements and optimize the use of clinical supply inventories.

Key Responsibilities Include:

  • Create and manage clinical trial demand forecasts and budgets with consistent and clear process outputs. Administer the forecasting process at multiple times and at multiple levels of granularity in alignment with downstream supply chain requirements. Through robust and formalized communication of key clinical demand drivers, organize and manage key forecast parameters which impact demand volumes and timings. Assess pertinent factors in determining and developing forecasts at either the program or protocol level.
  • Develop an understanding of clinical trial operational expectations by reviewing the study design, expected pace of enrollment, dosing schedule, study assumptions and resulting demand forecasts.
  • Support the organization in the creation and management of IRT algorithms based on predicted conduct of clinical trials and established forecasts.
  • For assigned programs, monitor the program portfolio to ensure adequate representation of clinical demand forecasts.
  • Collaborate with Supply Managers in understanding trial timing, asset strategy and study design/protocol availability.
  • Per a predefined business process, update previously established forecasts at a regular cadence and corresponding to the status of the program/protocols being forecasted (startup, maintenance, close-out).
  • Based on current information related to ongoing studies (real time activity, inventory levels, enrollment, etc.) collaborate with Clinical Supply team in reforecasting clinical demands. Aid in leveraging updated forecasts to inform current demand/supply plans and downstream operations.
  • Participate and/or lead business process development efforts in support of demand planning function, to increase the value of the forecasting function to both upstream and downstream stakeholders, as part of the CS&OP.
  • Contribute to the development and/or optimized use of information technology forecasting tools

Education, Registration & Certification:

  • The ideal candidate should have a Bachelor’s degree in life sciences /engineering or relevant work experience.

Experience:

  • 10+ years of progressive experience in clinical trials planning experience

Skills, Knowledge & Abilities:

  • Ability to characterize clinical trial requirements and synthesize data into forecasts of clinical trial expectations.
  • Ability to merge both firm and changing information sets into reasonable and defendable forecasts.
  • Prior experience within a clinical supply chain function; demonstrated experience in clinical forecasting and management of related IT tools such as forecasting scenario planning software, ERP/MRP software, IRT systems
  • Demonstrated understanding of clinical protocols and the creation and management of demand plans to support clinical protocols
  • Demonstrated nimble nature to adapt to the pace and dynamic nature of a fast paced environment; process data, information and feedback with speed and communicate outcomes, alternatives and impacts with appropriate urgency.
  • Passion for learning, creating, relating, communicating, and leading
  • Understanding of global regulatory compliance (GMP, GCP, and GDP)
  • Demonstrated success in implementing and supporting new processes in a dynamic environment
  • CMC / Manufacturing knowledge

Physical Demands and Work Environment: This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.