Associate Director/Sr. Manager, Clinical Supply Operations
Deciphera Pharmaceuticals
 Waltham, MA
Company Summary:
Deciphera Pharmaceuticals
is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.

We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
·       providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
·       a diverse and multi-disciplinary workforce
·       dedicated and talented people who are passionate about achieving excellence in all they do
·       a work environment that allows you to balance your priorities
·       above all else, a commitment to the patients we serve

We are seeking an Associate Director/ Sr. Manager of Clinical Supply Operations to manage day to day clinical supply activities and logistics within the Clinical Operations Group as further described below. This position will design, develop, and implement the clinical supplies strategy to ensure appropriate processes are established, and in order to achieve clinical supplies for key deliverables for each study within the program. This position will also manage supply chain activities for Phase I through commercialization and assist in the development and implementation of Investigational Supply Operations processes and procedures. 

This position will report to the Senior Director, Supply Chain and be located in the Waltham, MA office. 

Key Responsibilities:

  • Plans, establishes, manages and monitors forecast activities related to drug product, and clinical supplies for multiple programs and study level, based on clinical study protocol and clinical development plans. 
  • Responsible for all levels of studies, ranging from simple and complex, requiring in-depth understanding of GMPs, project management, IXRS, medication management and/or use of advanced simulation tools.
  • Independently responsible for development, and implementation of clinical supply plans, based on clinical development plans.
  • Responsible for scheduling and delivery of CTM including strategies for creating label and packaging design, randomization, packaging, labelling and distribution of clinical supplies.
  • Manages external consultants and third-party vendors, including collaboration with QA on vendor selection and quality and supplier agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
  • Ensures that key project milestones are met, negotiates and communicates supply plan timelines to internal and external customers and partners.
  • Develops and manages the forecasting and ordering investigational product, commercial and comparator material in global trials and share best practices with global/local sourcing teams as appropriate.
  • Independently creates clinical supply study budgets.
  • Monitors spend to-date compared to the approved study budget.
  • Accountable and responsible for amending budgets through defined change management processes.
  • Manages all finance activities with clinical team and clinical finance including request for proposal for bidding and vendor selection, purchase orders and invoice approval.
  • Ensures uninterrupted supplies throughout the duration of a clinical study program.
  • Maintains/tracks inventory of available clinical supplies and tracks expiration dates.
  • Coordinates with CMC, in-licensing and QA partners to manage technical and quality issues to facilitate uninterrupted supplies.
  • Proactively drives cross-functional activities.
  • Works with other line functions and external partners to manage complex projects.
  • Identifies potential system/technology improvements/enhancements.
  • Maintains and ensures compliance to all SOPs.
  • Identifies gaps and makes appropriate mitigation recommendations to ensure global compliance.
  • Develops new functional SOPs, Policies/Plans as necessary.
  • Provides training to staff.

Required Qualifications

  • 7 + years’ experience in the biopharmaceutical industry supporting complex global trials
  • Ability to effectively prioritize and manage multiple projects and tasks.
  • Possess a flexible approach to problem solving and strong negotiations skills.
  • A team player, who listens effectively and invites response and discussion.
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner.