What are the responsibilities and job description for the Director, Clinical Supply Chain position at BioSpace, Inc.?
Job Details
Job Title :
Director, Clinical Supply Chain
Location :
San Diego, CA / Hybrid / Remote
Position type : FLSA :
Full time
Exempt
Department : Finance ID :
TD&O
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. 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 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
What We Will Provide to You :
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O : 858-401-7900
F : 858-401-7901
Salary : $213,750 - $236,250
