Job Title: Director, Clinical Supply Chain
Location: San Diego, CA / Hybrid / Remote
Position type: Full time
FLSA: Exempt
Department: TD&O
Finance ID: 7625-B38246-BF
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.
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).
The Opportunity We are seeking a Director, Clinical Supply Chain, who is experienced and is a senior leader accountable to develop and execute Avidity's supply strategy across all clinical programs. The individual will be responsible for demand management, supply planning, vendor forecast management and cross-functional communication across Avidity's network. A strong knowledge of cGMP supply, experience working with IRT, labeling, kitting and clinical distribution operations, and knowledge of cGMP and FDA/EMA guidelines is required.
What You Will Contribute Provide operational leadership for one or more of Avidity's clinical programs, including demand/supply/capacity planning, sourcing, clinical labeling, packaging, inventory management, cold chain shipping, import/export, and distribution.Build and implement forecast models that can track changes in forecast requirements accurately and supply product for clinical studies.Support clinical packaging sites, as needed, and ensure clinical drug inventory levels are maintained in accordance with study plans.Support and develop appropriate Clinical Supply SOPs.Source and select clinical third-party vendors to support Avidity's global footprint of clinical studies.Identify, communicate risks to clinical program timelines due to manufacturing delays. Work cross-functionally to strategically manage inventory levels at various clinical depots.Provide support for regulatory filings IND, CTA, IMPD updates as needed.Develop appropriate regional labeling strategy to make optimal use of limited clinical inventory.Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.Supervise and help develop direct reports as assigned.What We Seek Bachelor's Degree in pharmaceutical sciences, supply chain, engineering or related field is required; Advanced Degree preferred.A minimum of 10+ years of Clinical Supply Chain management with 6+ years' experience managing and developing direct reports.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. Ability to support IRT user acceptance testing as well as IRT updates to support 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.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 $213,750 – $236,250. 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
#J-18808-Ljbffr