Manager, Clinical Supply Chain

Strive to Bring a Profound Difference to our Patients

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 Twitter.

The Opportunity

We are seeking a Manager, Clinical Supply Chain, who is experienced and can drive execution of Avidity’s supply strategy across all clinical programs. The individual will be responsible for inventory management 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

• Provide operational execution of one or more of Avidity’s clinical programs, including inventory monitoring, inventory management, labeling, sourcing and kitting.
• Track changes in forecast requirements and notify Clinical Supplies leadership of any potential stock-out risk or product expiry issues.
• Support clinical packaging sites, as needed, and ensure clinical drug inventory levels are maintained in accordance with study plans.
• Support for writing Clinical Supply SOPs, as needed.
• Support for Managed Access Program supply, as needed.
• Support Avidity’s global footprint of clinical studies and provide input on labeling strategy to support clinical need.
• Work cross-functionally with Clinical Operations to strategically manage inventory levels at various clinical depots.
• Provide support for regulatory filings IND, CTA, IMPD updates as needed.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

What We Seek

·          Bachelor’s Degree in pharmaceutical sciences, supply chain, engineering or related field is required; Advanced Degree preferred.

·          A minimum of 5+ years of working 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.

·          Knowledge of IRT system use and development.

·          Proven track record of effective collaboration with external providers.

·          Ability to coordinate support for clinical sites; experience with infusion-based therapies required.

·          Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.

·          Ability to travel as needed.

What We Will Provide to You:

·          The base salary range for this role is $142,500 - $157,500. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.

·          Avidity offers competitive compensation and benefits, including 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, including a variety of internal programming developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.