Executive Director, Clinical Supplies Planning And Logistics

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY

The Executive Director, Clinical Supplies Planning and Logistics is responsible for developing and implementing a comprehensive Clinical Supply Chain Management strategy and business processes that will allow Structure Therapeutics to scale effectively through clinical development. This position will provide leadership and direction on a cross functional basis to ensure that all clinical trials have timely and adequate supply for administration to study participants. This is both a strategic and execution focused role requiring someone to see the big picture, plan, and roll up their sleeves and get things done. Collaborates and interacts internally with Clinical Operations, Clinical Science, Program Management, Quality, Regulatory, CMC, Finance, and externally with Clinical Service Providers (e.g., CMOs, CROs, IP Drug Depot). The position will report to the Head of Clinical Development Operations.

Essential Duties and responsibilities

• Leads all aspects of IP supply planning, logistics, and sourcing of comparator and ancillary supplies to ensure alignment with study plans, timelines, budget, and overall clinical development plan
• Drives the strategic management of IP vendors (performance, quality, timelines, results, costs); participates in preparation of RFP, reviews CMOs, CROs and IP services vendors budgets (labeling, packaging, distribution; IRT). Acts as point of escalation for IP-related issues.
• Develops, leads, and manages relationships with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
• Responsibility for hiring, mentorship and oversight of Clinical Supplies Planning and Logistics staff, as well as selection and performance of external service providers
• Partners with SVP of Clinical Development Operations to set clear goals, objectives, and milestones that are consistent with departmental and corporate objectives and priorities
• Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
• Leads and manages clinical supply and Logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management
• Leads and manages the design, review, and approval of IP-related study documents (e.g., pharmacy manual, IP section of protocol)) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists
• Supports Clinical Operations and CMC teams for auditing and inspection of manufacturing sites Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub-team(s)

Core Competencies, Knowledge, and Skills

• Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
• Knowledge of technical transfers, qualification, validation, IND, NDA, FDA inspections, process scale-up
• Strong supplier management, project management, organizational, and planning skills
• Proven negotiation and influencing, and strong interpersonal skills to deliver value
• Proven ability to work in a lean organization and creatively solve problems
• Empathetic leader, who can recruit, retain, and develop talent
• Ability to work flexibly in a fast-paced environment with a strong work ethic and positive attitude
• Strong understanding and proven experience in IRT and other drug supply management systems, as well as experience in overseeing CROs and CMOs
• Knowledge of trade compliance, import/export policies
• The ability to prioritize and handle multiple activities on a daily basis yet flexible and responsive to frequently shifting priorities
• Demonstrated ability to integrate into a remote team environment (US, APAC) with a positive attitude
• Action-oriented with excellent problem-solving skills
• Strong sense of ethics and honesty
• Other qualitative requirements:
  • Organizational skills
  • Result-driven
  • Strategic agility
  • Resilience and flexibility dealing with ambiguity

REQUIREMENTS

Education

• BS and/or MS in a technical discipline

Experience

• 14 + years of relevant experience in the biotechnology/pharmaceutical industry, including at least 7 years in key leadership roles (Associate Director and above) in clinical supply management and/or CMC project management
• Experience in small molecules (capsule and tablet) clinical supply Planning and Logistics for multi-center, global studies required
• Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred as well as in North America and Europe required
• Experience in operations and systems, including replenishment planning capacity analysis, manufacturing, and distribution in a clinical or manufacturing environment
• Proven track record of building, managing, and developing the Clinical Supply Planning and Logistics function

The target salary range for this full-time role is $252,000 - $346,000 + bonus + equity + benefits.  Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.