Director, Clinical Supply Chain

2 weeks ago

Raleigh, United States Verona Pharma Full time
Job DescriptionJob DescriptionDirector, Clinical Supply Chain

The Company:

Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. Our first product is now approved by the US FDA for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults and we continue to develop our respiratory pipeline. We aim to provide relief for millions of patients suffering from a variety of respiratory conditions including cystic fibrosis (CF), non-CF bronchiectasis and asthma. Our focus is driven by our desire to ensure that innovative and differentiated molecules can reach these patients.

The experience of the Verona team, and its highly effective leadership allows us to challenge the status quo in drug development and commercialization. Verona provides a professional, diverse, and inclusive working environment where our employees thrive. We are driven to succeed by our desire to help those dealing with the chronic progressive nature of respiratory diseases. We offer you the opportunity to help create a new future for those people living with respiratory diseases.

The Opportunity:

Verona Pharma is currently recruiting a Director, Clinical Supply Chain to join our team, reporting to our Sr Director, CMC. In the role of Director, Clinical Supply Chain, you will be responsible for the strategic planning and execution of clinical program supply chains. You will successfully interpret and advise on a clinical trial protocol design with respect to supplies, in conjunction with key Clinical Operations, Regulatory Affairs and Quality Assurance colleagues.

Remote working and flexibility are important parts of our culture at Verona. However, we are looking for candidates based in the Raleigh/Durham/Chapel Hill area as you will periodically be required to go into the Raleigh office for key meetings, training, and other activities as needed.

To be successful in this role, you must apply best practices in the development, initiation, planning, execution, control and closing of projects.

We know our employees are our most valuable asset, and our culture conveys that.  Trust, accountability, and efficiency are core values that drive our working environment.  We have a unique opportunity to bring a first-in-class medication to chronic respiratory disease patients with significant unmet needs.  We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

Responsibilities:
 
  • Leads and is responsible for the planning and execution of clinical supply requirements for the clinical program ensuring, where required, timely API and drug product manufacture, packaging, labelling and distribution of clinical supplies for global clinical studies.
  • Act as key interface with Clinical, CMC, Regulatory and CRO teams and contribution to study protocol design, approving pack design and defining distribution strategy, as a member of the clinical development matrix team.
  • Responsible for forecasting, planning and contingency planning to ensure the provisions of clinical supplies for clinical studies in collaboration with Clinical, CMC, Regulatory and CRO teams and in alignment with clinical study timelines.
  • Responsible for clinical supply chain project management to ensure, in collaboration with CMC and CDMO colleagues, procurement and management of supply inventory, vendor oversight and management, shipping & receiving.
  • Executes high quality, integrated cross-functional plans for the management of clinical study supplies.  Key stakeholder in clinical study supplies vendor selection process and accounting for supplier/vendor-related relationship management; serves as point of escalation for vendor performance issues, internal customers, and cross-functional partners; acts as point of contact for clinical supply requirements.
  • Interacts collaboratively across internal company departments and external manufacturing, packaging and labelling Contract Development Manufacturing Organizations (CDMOs).
  • Designs and presents program-level forecasts and demand plans to members of Senior Management embracing investigational product, comparators, and ancillaries, as appropriate.
  • Authors Investigational Product Handling and Pharmacy Manuals, providing key drug supply and ancillary handling information.
  • Contributes to Regulatory submission documents and responses to Regulatory questions e.g. INDs, NDAs.
  • Represents the company’s clinical supplies function, presenting at Global Investigator Meetings.
  • Develops supply strategies to be adopted at the program level; oversees budgets at a program and study level, ensuring challenge, review, presentation, and approval of initial budget and adherence to the supplies budget through the lifecycle of the program.
  • Directs and oversees pack/label and distribution of clinical supplies for the duration of the clinical study through study completion and closeout, including resupply as needed.
  • Manages inventories at depots and sites and ensures on-time delivery with minimal overage of clinical supplies.  Coordinates purchasing activities with other departments to maintain inventory at planned levels. 
  • In-depth understanding of blinding, possible issues and maintaining the blind throughout the conduct of the studies.
  • Identifies supply risks and implements corrective actions and mitigation strategies to maintain supply continuity.
  • Ensures compliance with company internal procedures and GXP requirements by close collaboration with QA and Clinical Operations and approved vendors.
  • Subject matter expert for the IRT (Interactive Response Technology) drug supply and reconciliation modules. Key member of sponsor team with a strong understanding of patient randomization and strata and establishing IRT design and User Acceptance Testing supporting clinical teams.
  • Other duties as assigned.

Requirements:
 
  • Bachelor’s Degree (science or business degree preferred).
  • At least 10 years’ experience in Clinical Supply Chain Management within pharmaceutical/biotech, CMO or CRO Organizations.
  • Extensive experience in clinical forecasting including the ability to translate complex clinical trial designs into demand forecasts and supply plans.
  • Deep understanding of supply chain networks, IRT, GXP, Quality (GMP/GCP), clinical regulations with respect to IP in a pharmaceutical/biotech R&D environment.
  • Deep understanding of the IP and Medical Devices, Subject Matter Expert on Pharmacy, and dosing aspects of the IP.
  • Ability to develop new ways of working and the creativity to aid in establishing robust business processes.
  • Ability to successfully build trust and influence across all levels internally and externally.
  • Develop solutions for diverse and complex supply chain issues simultaneously for multiple studies.
  • Ability to make forecasting decisions that align work with organizational priorities, even in ambiguous situations.
  • Vendor selection process and management, and budget management experience.
  • Flexibility regarding schedule and work projects.
  • Strong Microsoft Office skills (Word, Excel, PowerPoint, Project etc.).
  • Ability and willingness to travel 10-15%, including domestic and international.

An Equal Opportunity Employer:

Verona Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Verona Pharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
 

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