Senior Director, Global Clinical Supply Chain (Open to Remote)
SENIOR DIRECTOR, GLOBAL CLINICAL SUPPLY CHAIN (Open to Remote)
This position is responsible for overseeing and managing end to end global clinical supplies management for GBT small and large molecule clinical development programs, while continuing to develop organizational capabilities, processes and systems. The Senior Director-Global Clinical Supply Chain will lead and shape the vision of the clinical supply chain group by providing guidance and direction to the team, working collaboratively with other teams as CMC, Regulatory Affairs, Clinical Development and Clinical Operations, among others. This position includes all elements of the clinical supply chain from the protocol design through manufacturing, distribution and inventory management of clinical supplies at clinical sites worldwide, including returns and destruction of clinical supplies. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed while placing a high value on cooperative team dynamics.
Essential Duties and Responsibilities:
- Leads end –to-end (E2E) clinical supply responsibilities including but not limited to protocol reviews, demand planning, supply planning, distribution and logistics, including reverse logistics activities, inventory management, investigational label text management, and planning and execution of packaging and labeling operations at partner contract manufacturing organizations (CMOs)
- Leads department in establishing and executing clinical supply management strategies for global clinical studies across GBT products lifecycle
- Review, maintain and implement required Standard Operating Procedures (SOP’s), business processes and systems needed to ensure effective operations
- Responsible for integrated forecasting and planning and supply strategies for the clinical supply chain. Perform modeling and scenario planning for short, medium and long-term range horizons. Integration with overall production planning process for GBT products
- Works collaboratively with Clinical Operations, CMC, Quality Assurance, Regulatory, and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP)
- Manage clinical supply inventory, expiry dates and inventory availability. Manage Jurisdictional Control process for clinical supplies
- Oversee vendor activities related to packaging, labeling and distribution for GBT multinational clinical studies. Effectively partners and collaborates with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors and develops comprehensive corrective actions to prevent recurrence
- Manage supply related areas related to IRT/IWRS systems and processes, including User Requirements (URS), User Acceptance Test (UAT) and system oversight
- Ensure global distribution and logistics processes are in place (Import/Export) for clinical supplies. Implement required processes to support Import License applications for shipments to non-conventional geographies
- Responsible for clinical labeling processes in compliance with applicable regulations, including processes around blinding, randomization, packaging design
- Develop, maintain and publish relevant Key Performance Indicators (KPI’s)
- Financial oversight of the clinical packaging and labeling vendors. Negotiates and evaluate costs and responsible for financial budgeting for clinical studies
- Key contributor in Study Execution Teams (SET), Clinical Strategy Team (CST), and related CMC and organizational meetings. Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, Technical Operations/ CMC, Project Management to develop ideal supply strategies to support availability of product to patients
- Support Regulatory submissions and participate in regulatory inspections as required
- Hire, mentor and develop staff – foster environment of innovation and growth by providing clear vision and direction to team. Develops organizational capabilities and focuses on continuous improvement of processes and related systems
- Stays current with latest developments on regulatory and industry landscape and best practices on the clinical supply chain arena
- Form and lead cross-functional teams as required. Timely and effective communication across functional areas, team, partners and any impacted stakeholders. Represent Clinical Supply Chain in cross-functional/inter-departmental initiatives
- BS/BA or MS/MA, degree in related discipline and/or 12-17+ years of related industry experience
- Previous experience leading end to end clinical supply management required, including early phase, late phase as well as Investigator Sponsored Studies (IST’s). Demonstrated experience with implementing procedures, building and shaping a clinical supply organization
- Experience and knowledge in forecasting including demand and supply planning. Experience with implementing IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export and logistics.
- Experience with CMC modules Regulatory Submissions for Investigational Product, active participation in Health Authority audits
- Strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.
- In-depth understanding of CMC and manufacturing processes, Quality Assurance, Clinical Operations
- Effective negotiator and relationship builder. Technical experience in manufacturing operations - drug product manufacturing, project management, packaging and labeling
- Experience with regulatory submissions and participations in Health Authority audits
- Previous supervisory experience required
- Experience with small and large molecule products. Cold Chain logistics experience a plus.
- Experience with regulatory submissions and active participation in Health Authority audits
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.