Job Description

Primary Function

DiaMedica Therapeutics (NASDAQ:DMAC) is a clinical-stage biopharmaceutical company developing novel recombinant proteins for neurological and cardio-renal diseases. The company comprises a team of seasoned biopharma professionals and financial experts who are moving the company’s proprietary products through clinical trials and to commercialization.

The Assoc. Director Clinical Supplies will work closely with the SVP of Clinical Development Ops. to be responsible for ensuring that the appropriate clinical supplies needed for DiaMedica clinical studies are provided on time and in accordance with protocol and applicable regulatory requirements. This includes management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies. The successful candidate will collaborate closely as a member of cross-functional study teams that include CMC, Clinical Operations, RA/QA, and have some vendor management responsibilities interacting with CRO(s), depot(s), IRT vendor(s), and ancillary procurement vendor(s) as applicable. The candidate may also perform some traditional Clinical Operations functions as well, including interacting with sites on clinical supplies and other matters.

Major Responsibilities

• Closely collaborate with Clinical Operations and CMC to provide leadership, planning and execution of Clinical Supply Chain activities to support DiaMedica clinical studies globally
• This position collaborates closely with CMC and Clinical Operations to manage operations including clinical packaging, labeling, and distribution.
• Develop study-specific Investigational Product Supply Plans and manage the development of Pharmacy Manuals and supply-related training/instructional videos/compliance documentation
• Identify supply accountability tracking and ensure Master, Pharmacy, Subject Logs are appropriate in collaboration with the CRO and Clinical Monitoring team.
• Ensure appropriate document of IP supply activities is provided in each Trial Master File.
• Manage supply planning/forecasting to ensure alignment with study activity and timelines in each region.
• Coordinate procurement, handle temperature excursions and site inquiries, and ensure expiry extensions are provided to depot/sites as needed to support continued use.
• Collaborate with the study team and vendors to assure proper distribution of supplies to study sites.
• Manage return and destruction of clinical supplies, with proper documentation of all steps.
• Serve as primary Operations point of contact for internal CMC department, and third-party packaging, distribution, and storage vendors.  Serve as primary vendor manager for central pharmacy and collaborate with clinical operations on home nursing procedures around drug administration.
• Manage approval of the packaging, logistics service agreements and study-specific plans. 
• In conjunction with CMC and regulatory, review and coordinate approval of investigational supply label text and proofs to meet specific country language(s), translations, and regulatory requirements.
• Liaise with appropriate parties internally and externally to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person (QP) release, CoA, Certificates of Compliance)
• Work with cross-functional team to develop study-specific IRT specifications and requirement documents providing IP and ancillary supplies management perspective
• Perform unblinded monitoring of IRT inventory and functionality monitoring to assure resupply generation occur within defined specifications
• Serve as the unblinded sponsor representative to vendors and sites, including unblinded monitoring report reviewer (reports will be generated by an unblinded CRA), and trouble-shoot while maintaining the blind.
• Responsible for actively contributing to all Quality Systems related to the Clinical Supply Chain including deviations, investigations, CAPA's, and Change Control
• The Associate Director will be the subject matter expert related to clinical drug supply during regulatory inspections
• Complete quarterly business and performance metrics
• Negotiate quotes and work orders for new trials under the direction of the SVP, Clin Dev Ops
• Provide clinical supplies leadership and support for IND and NDA filings as required
• Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements. Establish SOPs, protocols, and procedures for ancillary supplies as well.
• Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities, ancillary supplies vendors, depots, etc., as required
• Proactively address risk management issues and implement business continuity plans
• Prepare supply and cost forecasts, accruals, overall budgets related to clinical supplies and ancillary supplies as required
• Identify cost reduction opportunities and develop and manage clinical supply budget
• Consistent with a small company environment, during times of peak workload, this person may be asked to contribute to other clinical operations / study management tasks as needed.
• Ensure the quality of clinical-supplies-related deliverables.
• Ensure compliance with own Learning Curricula, corporate and GXP requirements

Qualification Requirements

• Bachelor's degree with 7+ years experience in Clinical Drug and/or Ancillary Supply Management Operations in the biotech/pharmaceutical industry. Clinical Operations experience may be acceptable with a strong focus on Clinical Supplies. 
• Experience with biologics and/or proteins is a plus. Experience with IV formulations and subcutaneous injections is required, including IV ancillary supplies and familiarization with IV setups.
• Global experience including at a minimum – US, Canada, Australia, New Zealand, Europe. Other APAC country experience is a plus.
• Ability to work cross functionally with multiple internal teams and external CMOs
• Experience designing kits including main IMP and ancillary supplies.

Experience working with global CROs

• Working knowledge of cGMPs and pharma industry procedures and regulations
• Experience with IRT implementation
• Experience with temperature-controlled shipments and managing temperature excursions
• Experience working with FDA and other global health authorities
• Knowledge of import/export processes and regulations
• Proven success managing clinical trial logistics and clinical supply depots
• Demonstrated excellence in project management-managing, tracking, and measuring project progress
• Excellent written and verbal communication skills including ability to write clearly and concisely. If a remote employee, must be an excellent communicator and be able to build relationships with other employees
• Top notch interpersonal skills in difficult situations
• Driver of change and innovation
• Ability to work seamlessly with all levels of personnel
• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
• Excellent word processing, SharePoint, excel, e-mail, and online meeting tool skills
• Must have proven track record to be able to think critically, strategically, independently and problem solve
• Must have high level of motivation, drive, and demonstration of leadership values

Work Environment

This position resides remotely or within a normal office working environment with very little travel required. If remote, occasional travel to the corporate headquarters in Minnetonka, MN is required.

EEOC Statement

DiaMedica Therapeutics Inc. believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.