Associate Director, Clinical Supply

Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and X.

The Opportunity

We are seeking an Associate Director, Clinical Supply Chain, who is experienced and can drive execution of Avidity’s supply strategy across all clinical programs. The individual will be responsible to provide operational leadership of materials at our depots and clinical sites, daily monitoring of the IRT, managing label proofs and packaging vendors and assisting with the closure of critical deviations and nonconformances. A strong knowledge of cGMP supply, experience with vendor management, labeling, kitting and clinical distribution operations, and knowledge of FDA/EMA guidelines is required.

What You Will Contribute

• Oversee packaging, labeling, and distribution activities for investigational drugs, ensuring compliance with quality and regulatory requirements and industry standards. This includes requesting and reviewing proposals, communications of project requirements, and management of project execution.
• Manage the development of study specific labels that comply with SOPs and applicable regulations.
• Responsible for the labeling, distribution, returns, reconciliation, and destruction of supplies to support global clinical studies at all phases of development for rare diseases
• Manage batch record review and release of packaging/labeling activities of clinical supplies
• Manage and optimize inventory levels of investigational drugs across multiple clinical trials at clinical trial sites and depots, accounting for study requirements, patient enrollment projections, and site demand forecasts.
• Procurement and management of study drug, ancillary supplies, co-drugs/comparators, and medical devices/equipment.
• Manage internal and third-party deviations, customer complaints, and change controls
• Participate in the selection, design, configuration, review, and User Acceptance Testing of IRT systems for drug supply management, accountability, and randomization of global clinical studies
• Ensure all study related GMP documents are accurate and filed in a timely fashion in the TMF as per the Good Manufacturing Practices and Good Clinical Practices guidance.
• Maintain inspection readiness for activities pertaining to labeling and distribution practices
• Manage and resolve supply chain related issues such as temperature excursions, shipment related incidents, and other time sensitive issues

What We Seek

• Bachelor’s Degree in pharmaceutical sciences, supply chain, engineering or related field is required; Advanced Degree preferred.
• A minimum of 7 years of hands-on working experience in Clinical Supply Chain
• Experience working with third-party CMOs manufacturing cGMP clinical supplies (labeling, kitting, clinical supply serialization, etc).
• Experience supplying clinical product to US, Canada, UK, EU, APAC and LATAM.
• Experience with Excel at a minimum.  Experience with external clinical forecasting systems (i.e. Signant Health) is a plus.
• Must have hands-on working experience in global IRT systems.
• Proven track record of effective collaboration with external providers.
• Ability to coordinate support for clinical sites; experience with infusion-based therapies required.
• Demonstrated ability to facilitate project team meetings, enhance cross-functional communication.
• Ability to work flexible business hours to communicate with global business partners.
• Ability to travel as needed.

What We Will Provide To You

• The base salary range for this role is $180,500 - $199,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits, which include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.