< Back to Careers

Director/Senior Director, Clinical Drug Supply

Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.

Position Summary 

Sionna Therapeutics is seeking a Director/Senior Director, Clinical Drug Supply, to work collaboratively with internal teams, external vendors and stakeholders across its clinical programs to support clinical trials and ensure compliance with regulatory standards. This leader is responsible for overseeing the end-to-end management of clinical drug supplies which will involve strategic planning, coordination and execution of supply chain activities to ensure the timely and efficient delivery of clinical drugs in support of Sionna’s development programs.

Working closely internally with Development Operations, CMC, Clinical Operations, Quality, Regulatory and Finance functions, this candidate will lead drug supply vendor selection, relationship-building, SOP development, and create and maintain standards for Sionna clinical drug supply chain excellence. This will include selection of drug supply-related vendors and depots, demand/supply/capacity planning, sourcing, labeling, packaging, inventory management, shipping, and distribution.

We are accepting resumes for the position at careers@sionnatx.com.

Key Responsibilities:

  • Provide strategic and operational leadership of the global drug supply chain function and disciplines for first in human as well as later stage programs
  • Lead vendor identification, selection, onboarding, management and oversight for single and combo agent/comparator sourcing and packaging and distribution.
  • Develop and implement clinical supply chain strategies for clinical supply plans, forecasts, packaging, labeling and distribution to support program needs and provide vendor oversight
  • In collaboration with Quality, Regulatory and third party vendors, develop drug product and finished goods labeling strategies, and support the process for label generation and approvals, including regulatory variations and translation activities
  • Generate global distribution plans, including depot inventory, site seeding, and re-supply strategy with appropriate lead-time, expiry dates, and replenishment quantities (via IRT or manually)
  • Liaise with CMC on DP forecasting to monitor and plan appropriately for drug substance and drug product clinical needs, and program milestones, such as scale-up and/or technical transfer
  • Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, and internal milestone timelines to develop forecasts and associated supply/distribution plans
  • Work with the Clinical Operations and Clinical Development functions to facilitate study drug logistics with the drug supply vendor and clinical sites to assure product availability and management in support of all clinical trials.
  • Work with the drug supply vendor and CMC to develop the process and method for study drug storage, preparation and administration for each clinical study
  • Author or contribute to, review, and/or approve related clinical and technical documents, including clinical label text, clinical/master batch records, clinical trial protocols, IBs pharmacy manuals, INDs, IMPDs, and NDAs
  • Co-develop the specification, assist in user acceptance testing and management for RTSM/IRT systems
  • Identify central and local depots and regional hubs
  • Monitor distribution activities and inventory levels and drug expiry at investigational sites
  • Partner with Regulatory, Quality and CMC leads as appropriate to proactively identify critical path/risks to the drug supply chain function and drive the development and communication of mitigation strategies
  • Work with Clinical Development and CMC to generate, maintain and circulate regular supply forecasts and drug consumption reports.
  • Establish internal Supply Chain infrastructure to navigate and manage all planning, development and manufacturing related documentation and tools
  • Contribute as an active core member in study teams and other cross-functional meetings
  • Participate in the creation and/or review of departmental SOPs and controlled documents to ensure compliance with cGMP and company SOPs
  • In collaboration with Finance and Legal teams, manage the negotiation of contracts broadly across the supply chain with new and established suppliers, distributors, and vendors
  • Responsible for budgeting process for clinical drug supply activities; contribute to the CMC budgeting process and work closely with Finance on determining cost of goods etc.
  • Additional tasks and responsibilities as required

Minimum Qualifications:  

  • 8+ years in drug supply management within the pharmaceutical/life science industry with experience building and/or managing a drug supply team; global clinical trial experience is strongly preferred
  • Bachelor’s Degree in a life-science-based subject, advanced degree preferred
  • Comprehensive understanding of small molecule and solid oral dosage form development, regulatory and quality
  • Working knowledge of import and export laws and processes
  • Working knowledge of pharmaceutical drug product development and manufacturing in early and later phases of development
  • Proven track record working with Clinical Operations, GMP, CMC, Regulatory and Quality in the biotech or pharmaceutical industry
  • Solid understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the US and other regions related to clinical drug supply
  • Excellent communication skills, both written and verbal, and track record of keeping key stakeholders and management informed of status, issues and recommended solutions.
  • Excellent organizational skills and ability to work independently
  • Ability to work in a small organization, multitask with changing priorities and manage tasks in a fast-paced environment.