Avidity Biosciences
Director, Clinical Supply
Avidity Biosciences, San Diego, California, United States, 92189
Job Title:
Director, Clinical SupplyLocation:
San Diego, CA / Hybrid / RemotePosition type:
Full timeFLSA:
ExemptDepartment:
CMCStrive 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 Director, Clinical Supply Chain 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, supply planning, vendor forecast management and cross-functional communication across Avidity’s network. A strong knowledge of cGMP supply, working knowledge of cGCP, experience working with IRT, manufacturing and distribution operations, and knowledge of cGMP and FDA/EMA guidelines is required.This position will work cross-functionally with clinical development, legal, finance, regulatory affairs, quality assurance, and IT.What You Will Contribute
Provide operational leadership for one or more of Avidity’s programs, including demand/supply/capacity planning, sourcing, clinical labeling, packaging, inventory management, cold chain shipping, import/export, and distribution.Build and implement forecast models 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 Supply Chain SOPs.Source and select clinical third-party vendors to support Avidity’s planned global footprint.Identify and communicate risks to clinical program timelines from manufacturing delays.Develop appropriate supply risk mitigation strategy via inventory planning.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:
Minimum Bachelor’s degree in supply chain, pharmaceutical sciences, engineering, or related field required.A minimum of 7 years of Clinical Supply Chain management.A minimum of 3 years of experience managing and developing direct reports.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.Knowledge of IRT system use and development.Knowledge of cGMP, ICH, FDA, and 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.Ability to travel as needed.What We Will Provide to You:
The base salary range for this role is $207,000 - $230,000. The final compensation will be commensurate with factors such as relevant experience, skill set, 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 medical, dental, vision, and LTD coverage 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.
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Director, Clinical SupplyLocation:
San Diego, CA / Hybrid / RemotePosition type:
Full timeFLSA:
ExemptDepartment:
CMCStrive 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
and
Twitter .The Opportunity
We are seeking a Director, Clinical Supply Chain 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, supply planning, vendor forecast management and cross-functional communication across Avidity’s network. A strong knowledge of cGMP supply, working knowledge of cGCP, experience working with IRT, manufacturing and distribution operations, and knowledge of cGMP and FDA/EMA guidelines is required.This position will work cross-functionally with clinical development, legal, finance, regulatory affairs, quality assurance, and IT.What You Will Contribute
Provide operational leadership for one or more of Avidity’s programs, including demand/supply/capacity planning, sourcing, clinical labeling, packaging, inventory management, cold chain shipping, import/export, and distribution.Build and implement forecast models 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 Supply Chain SOPs.Source and select clinical third-party vendors to support Avidity’s planned global footprint.Identify and communicate risks to clinical program timelines from manufacturing delays.Develop appropriate supply risk mitigation strategy via inventory planning.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:
Minimum Bachelor’s degree in supply chain, pharmaceutical sciences, engineering, or related field required.A minimum of 7 years of Clinical Supply Chain management.A minimum of 3 years of experience managing and developing direct reports.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.Knowledge of IRT system use and development.Knowledge of cGMP, ICH, FDA, and 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.Ability to travel as needed.What We Will Provide to You:
The base salary range for this role is $207,000 - $230,000. The final compensation will be commensurate with factors such as relevant experience, skill set, 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 medical, dental, vision, and LTD coverage 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.
#J-18808-Ljbffr