Senior Director, Clinical Supplies Management-617044 - Planet Pharma : Job Details

A mid-sized life science company in the Northeast is looking to add a Senior Director, Clinical Supplies Management to their team. In this role you will be responsible for oversight of Clinical Trial Material (CTM) / Investigational Medicinal Materials (IMP) planning and execution activities, supporting Phase 1-IV and IIS trials. Additional duties include leading a team of Clinical Supply Managers who ensure uninterrupted availability of CTMs/IMPs, running a CTM/IMP group vision to ensure the CTM/IMP team is well positioned to support existing and sustained growth to support clinical studies (Global & US), develop and continuously assesses clinical supply chain strategy, evolution of technologies, and industry trends. Acts as the functional owner for the CTM group and subject matter authority for Clinical Supply Chain Management, strategic multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results related to drug product development in reports and certificates of analysis.

• Education/Experience/Skills:A minimum of a BS/BA in Chemistry, Supply Chain Management, or related field. Master's degree is preferred. An equivalent combination of relevant education and applicable job experience may be considered.
• A minimum of 12 years of clinical supply management experience demonstrating a dynamically increasing scope of responsibility.
• A minimum of 5 years in a clinical supply leadership role with US and international clinical trial experience is required.
• Must be an expert in GXP requirements and is knowledgeable of industry services providers, trends, and challenges.
• Strong understanding of regulatory requirements impacting the clinical supply chain is required.
• Strong understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH guidance, 21 CFR Part 211, 21 CFR Part 11).
• Working knowledge of United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP), British (BP) and other established pharmacopoeias.
• Strong understanding of EU and EC CTR regulations.
• Skilled at negotiating with business partners, stakeholders, service providers.
• Proficient in the ability to influence and inform senior level leaders regarding matters of significance to the department.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
• Ability to travel up to 30% of the time both domestically and internationally.
• Primary Responsibilities:Establishes vision and strategic direction for CTM function and lead CTM supply team meetings.
• Ensures operational efficiency and compliance of supply chain processes compliance for packaging, labeling, sourcing, and distribution logistics.
• Identifies existing process/capabilities gaps; Prioritizes and sponsors strategic supply chain initiatives to address gaps.
• Establishes department standards and collaborates with cross functional partners to agree on expectations.
• Develops clinical supply chain resource plan to position the CTM group for future scalability.
• Defines department digital supply chain system needs.
• Provides Leadership to Clinical Trial Material Team
• Ensures CTM team effectively plans and implements in accordance with Study Team timelines.
• Defines expectations of CTM team and holds team accountable.
• Creates career development plans for CTM team members.
• Mentors CTM team
• Align operational execution practices across team members.
• Accountable for department budget
• Defines forward-looking functional team budget and tracks spending against the budget plan.
• Identifies opportunities for cost savings and develops plans for implementation.
• Partners with Finance and Procurement to ensure financial transparency.
• Establishes relationships and collaborates with cross functional leadership including but not limited to Clinical Operations and GMP Quality to align on business timelines and priorities.
• Implements strong Vendor Management oversight model for Clinical Supply Chain Vendors.
• Leads Business Review Meetings.
• Identifies opportunities with vendors and negotiates cost saving incentives.
• Leads escalation of issues to vendor Sr. Management.