Associate Director/Director, Clinical Supply
Hybrid - San Diego and Remote
$160,000 - $227,000
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/Director, Clinical Supply who is experienced, highly energetic, and committed to helping develop and execute Avidity’s supply strategy across all clinical and commercial programs. The individual will be responsible for demand management and inventory tracking in Avidity’s ERP system, supply planning, vendor forecast management, logistics and cross-functional communication across Avidity’s network. A strong knowledge of cGMP supply, experience working with manufacturing and distribution operations, and knowledge of cGMP and FDA/EMA guidelines is required.
- Provide operational leadership for Avidity’s global Clinical supply chain function, including demand/supply/capacity planning, sourcing, clinical labeling, packaging, inventory management, cold chain shipping, import/export, and distribution.
- Track changes in forecast requirements for pre-clinical and clinical studies.
- Support clinical packaging sites, as needed, and ensure clinical drug inventory levels are maintained in accordance with study plans.
- Support logistics operations of import/export of GMP and non-GMP materials.
- Ensure full compliance with import permit, customs duties and VAT requirements for clinical material shipments and develop appropriate Supply Chain SOPs to support.
- Source and select clinical third-party vendors to support Avidity’s planned global footprint.
- Identify, communicate risks to clinical program timelines from manufacturing delays.
- Develop appropriate supply risk mitigation strategy via inventory planning.
- Manage manufacturing plans and accruals across all CMOs and ensure communication of forecasts to manufacturing partners.
- Establish policies and procedures to support Avidity Development programs.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
- Establish excellent working relationships within the CMC team, QA, Legal and Finance to reinforce ways to efficiently manage and report on flow of product, information and cash.
- Minimum Bachelor’s degree in supply chain, pharmaceutical sciences, engineering, or related field required.
- Minimum of 7 years of pharmaceutical industry experience in supply planning.
- Experience in Clinical Supply required, along with a strong understanding of cGMP and cGCP regulations.
- Experience working with third-party CMOs manufacturing cGMP clinical supplies.
- Experience with MS Project and Excel at a minimum. Experience with ERP systems is a plus (Dynamics 365).
- Knowledge of import/export regulations, including pro-forma invoice generation and global trade compliance.
- Knowledge of IRT system use and development.
- Knowledge of cGMP, ICH, FDA, EMA guidelines regarding temperature controlled cold chain shipping requirements.
- Proven track record of effective collaboration with external providers.
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
10578 Science Center Dr. Suite 125
San Diego, CA