Associate Director, Clinical Supply
At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.
We are seeking an Associate Director Clinical Supply who is experienced, highly energetic, and committed to developing and executing Avidity’s supply strategy across all GMP programs. This individual will be responsible for working with the clinical development teams to determine study drug requirements and developing the manufacturing plans to support each study. In addition, the Associate Director Clinical Supply will track cGMP inventory across all stages of manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of trial design and experience working cross-functionally with clinical operations as well as knowledge of cGMP and FDA/EMA guidelines is required. The Associate Director Clinical Supply will also provide support for Avidity’s cGMP shipping and logistics and be part of several development teams.
Essential Duties and Responsibilities
- Assume responsibility for tracking changes in forecast requirements for pre-clinical and clinical studies.
- Work with clinical operations to align on study enrolment curves and vial demand across all studies.
- Track mAb, drug substance, SiRNA, PMO and DP inventory across all internal and external manufacturing sites. Work with the stability team lead to ensure that expiry and retest dating is current and fully aligned with the supply plan.
- Support clinical packaging sites, as needed, and ensure clinical drug inventory levels are maintained in accordance with study plans.
- Manage the manufacturing plans across all CMOs and ensure communication of forecasts to manufacturing partners.
- Support logistics operations of import/export of clinical materials.
- Support year-end cycle counts at vendor locations.
- Work with Quality team to establish temperature monitoring policy at the shipping conditions established for all GMP materials.
- Ensure full compliance with import permit, customs duties and VAT requirements for clinical material shipments in accordance with Supply Chain SOPs.
- Support management of logistics suppliers, customs brokers and GMP material storage warehouses, as needed.
- Identify and communicate risks to clinical programs due to manufacturing delays.
- Participate in developing appropriate risk mitigation via inventory management.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
- Minimum Bachelor’s degree in supply chain, pharmaceutical sciences, engineering, or related field required.
- Minimum of 8 years of pharmaceutical industry experience in supply planning.
- Experience in Clinical Supply required, along with strong understanding of cGMP and cGCP regulations.
- Experience working with third-party CMOs manufacturing cGMP clinical supplies.
- Experience with MS Project, Excel, minimum. Experience with ERP systems a plus (Dynamics 365).
- Knowledge of import/export regulations, including pro-forma invoice generation and global trade compliance is preferred but not required.
- Knowledge of cGMP, ICH, FDA, EMA guidelines regarding temperature controlled cold chain shipping requirements.
- Proven track record of effective collaboration with external logistics providers.
- Proven ability to thrive and enable success in a cross-functional and collaborative environment.
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
- Ability to multi-task, manage conflict, and work in a fast-paced environment.