Associate Director/Director, Clinical Supply at ARAVAS INC

, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Aug, 26

Salary

210000.0

Posted On

29 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Supply Planning, Procurement, Labeling And Packaging, Distribution Strategy, Inventory Management, IRT Implementation, GXP Compliance, Project Management, Cross-functional Leadership, Vendor Management, Budgetary Compliance, SOP Development, Import/Export Requirements, Analytical Thinking, Problem Solving, Microsoft Office

Industry

Pharmaceutical Manufacturing

Description

Job Summary Reporting to the Executive Director, Logistics & Supply Chain, the Associate Director/Director, Clinical Supply will be instrumental in ensuring the availability of supply to patients currently receiving Molgramostim treatment in our clinical trial and expanded access programs. The individual will serve as a key point of contact cross-functionally within the organization. Core Responsibilities * Works with internal stakeholders to translate clinical study forecasts into clinical supply plans. Key functions include planning, procurement, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all investigational programs. * With guidance from the Executive Director, Logistics & Supply Chain, maintains the overall labeling, packaging, and distribution strategy for all investigational programs. * Oversees the management of clinical supply activities at clinical packagers and depots to ensure efficient utilization of supply. * Manage label lifecycle process to ensure compliance with regulatory requirements. * Monitor patient activity and inventory levels at clinical sites and depots proactively to mitigate the risk of a supply disruption. * Manage funds and resources efficiently and with an entrepreneurial approach to ensure budgetary compliance. * SOP/Work Instruction development and management to support day to day operations. * Work with CROs to ensure import/export requirements are evaluated to enable the compliant movement of supply. * Other duties and projects as assigned. Required Qualifications * Bachelor’s degree required * 5+ years experience in planning, scheduling, and coordination of clinical supply activities globally * Strong GXP focus and compliance mindset * Demonstrated experience with implementing and managing inventory systems (IRT) * Ability to foster teamwork and project management within a cross- functional environment is critical * Strong interpersonal and communication skills and the ability to effectively drive performance * Excellent written and verbal communication skills in English * Analytical thinker with excellent problem-solving skills and the ability to adapt to shifting priorities and deadlines * Experience in managing external service providers (e.g., Clinical packagers, CDMOs, consultants, vendors) * Proven ability to develop exceptional relationships and have an impact on or appropriately influence others * Experience working in a start-up and/or mid-cap sized company highly desired * Proficient in the use of Microsoft Applications (Excel, Project, SharePoint, Word) Work Schedule and Location * This role is remote within the US and requires availability to work US Eastern Time Zone. * Travel to Savara's HQ outside of Philadelphia will be occassionally required. Savara provides Comprehensive Benefits including: * Medical, dental, and vision coverage * Flexible Spending Account for health care and dependent care expenses and Health Savings Account * Paid time off and paid holidays, including Dec 24-Jan 1 * Paid parental leave * 401(k) with highly competitive match * Life, AD&D, STD and LTD insurance coverage * Other supplemental insurance programs Savara’s compensation for this role will include a base salary, bonus, and equity. This role will be filled at the Associate Director or Director level. The base salary range for this role is $140,000 to $210,000. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization. #LI-Remote

Responsibilities

The role involves translating clinical study forecasts into supply plans and managing the procurement, labeling, and distribution of clinical supplies. It also requires overseeing external service providers and ensuring regulatory compliance for global supply movement.