Executive Director, Clinical Supply Chain
Location: San Diego
Posted on: June 23, 2025
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Job Description:
Job Title: Executive Director, Clinical Supply Chain Location:
Hybrid Position type: FLSA: Full time Exempt Department: Finance
ID: TD&O 7625-Q224-29 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 an Executive Director,
Clinical Supply Chain, who is experienced in building and managing
clinical supply teams and is a senior leader accountable for
developing and executing Avidity’s clinical supply strategy. The
individual will report to the Vice President, Global Supply Chain
and be accountable to manage supply across all of Avidity’s
clinical programs. As Avidity expands and strengthens its global
supply network, our team and systems will expand accordingly.
Overall responsibility will include clinical demand and supply
planning, vendor forecast management, IRT support and ownership of
labeling, kitting, and clinical distribution operations. A strong
knowledge of cGMP and global clinical supply requirements is
required. What You Will Contribute Lead Avidity’s clinical supplies
team including support of existing team member career development,
recruitment of new members and development of Clinical Supply
organizational structure Provide strategic leadership for all of
Avidity’s clinical programs, including demand/supply/capacity
planning, label development (including translations), global
labeling strategy, packaging and kitting operations, inventory
management and support for cold chain shipments as needed (i.e.
temperature excursions). Partner with Executive Director,
Commercial Supply Chain to strengthen clinical supply forecast
models to feed into Avidity’s S&OP process. Manage
implementation of Avidity’s clinical forecasting tool. Provide
strategic and operational ownership of all clinical packaging
sites, monitor site performance with business reviews and KPIs and
provide leadership for expansion of CRO vendor network. Ensure
clinical drug inventory levels are maintained in accordance with
study plans and that inventory is strategically positioned in
accordance with enrolment projections. Provide support for
Avidity’s pharmacy manuals and investigator brochures, as required.
Strengthen procedural elements of the clinical supply team
including review, development and maintenance of Clinical Supply
SOPs. Ensure accurate and timely communication to Program teams of
any clinical supply risks. Work cross-functionally to strategically
manage clinical inventory in accordance with manufacturing
schedules and regulatory submission/approvals. Provide support for
regulatory filings IND, CTA, and IMPD updates as needed. Respond to
RFIs in a timely manner in partnership with Regulatory. Develop
appropriate regional labeling strategy to make optimal use of
limited clinical inventory. Monitor pharmaceutical preparation and
dose administration questions from clinical investigator sites and
develop Avidity’s response strategy. Assist in pull-forward of
Avidity’s clinical/site experience to newly forming commercial and
medical teams preparing for launch. Ensure adherence to applicable
regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies
and procedures. Support Avidity QMS and RIMS systems as needed.
What We Seek · Bachelor’s Degree in pharmaceutical sciences,
chemistry, biology, engineering or related field is required;
Advanced Degree preferred. · A minimum of 12 years of Clinical
Supply management with 12 years’ experience managing and developing
direct reports. · Experience working with third-party CMOs
manufacturing cGMP clinical supplies (labeling, kitting, clinical
supply serialization, etc). · Experience with dose calculations for
weight-based infusions. · 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 or other) is a plus. · Knowledge of IRT system
sourcing, development, and use. Ability to support IRT user
acceptance testing as well as required updates to system for
implementation of study protocol changes. · Knowledge of cGMP, ICH,
FDA, EMA guidelines regarding temperature controlled cold chain
shipping requirements. Ability to coordinate requirements with
Avidity’s shipping & logistics team. · Proven track record of
effective collaboration with external providers. · 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 $270,750 – $300,000. 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. Avidity Biosciences 10578 Science Center Dr. Suite 125 San
Diego, CA 92121 O: 858-401-7900 F: 858-401-7901 LI-DNI
Keywords: , Oceanside , Executive Director, Clinical Supply Chain, Science, Research & Development , San Diego, California