Associate Director Clinical Supply
Associate Director Clinical Supply
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Job Description
Description
Job Title:
Associate Director Clinical Supply
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
TD&O
3101K11639BF
Profoundly Improve Peoples lives by Revolutionizing the Delivery of RNA Therapeutics
At Avidity Biosciences we are passionate about the impact of every employee in realizing our vision of improving peoples 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 solutionoriented 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 peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visit www.aviditybiosciences and engage with us on LinkedIn and X.
The Opportunity
We are seeking an Associate DirectorClinicalSupply Chainwhois experienced andcan drive ofAviditys supply strategy across all clinical programs. The individual will be responsible to provide operational leadership of materials at our depots and clinical sitesdaily 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 experiencewith vendor managementlabeling kittingand clinical distribution operations andknowledge of FDA/EMA guidelines is required.
What You Will Contribute
- Oversee packaging labeling and distribution activities for investigational ensuring compliance with quality and regulatory requirements and industry standards. This includes requesting and reviewing proposals communications of project requirements and management of project .
- Manage the development of study specific labels that comply with SOPs and applicable regulations.
- Responsible for the labeling distribution returns reconciliation and destruction of supplies to support global clinical studies at all phases of development for rare diseases
- Manage batch record review and release of packaging/labeling activities of clinical supplies
- Manage and optimize inventory levels of investigational across multiple clinical trials at clinical trial sites and depots accounting for study requirements patient enrollment projections and site demand forecasts.
- Procurement and management of study drug ancillary supplies codrugs/comparators and medical devices/equipment.
- Manage internal and thirdparty deviations customer complaints and change controls
- Participate in the selection design configuration review and User Acceptance Testing of IRT systems for drug supply management accountability and randomization of global clinical studies
- Ensure all study related GMP documents are accurate and filed in a timely fashion in the TMF as per the Good Manufacturing Practices and Good Clinical Practices guidance.
- Maintain inspection readiness for activities pertaining to labeling and distribution practices
- Manage and resolve supply chain related issues such as temperature excursions shipment related incidents and other time sensitive issues
What We Seek
- Bachelors Degreein pharmaceutical sciencessupply chainengineering or related field is required; Advanced Degree preferred.
- A minimumof7 yearsofhandson working experience in Clinical Supply Chain
- Experience working with thirdparty CMOs manufacturing cGMP clinical supplies (labeling kitting clinical supply serialization etc).
- Experience supplying clinicalproduct to US Canada UK EU APAC and LATAM.
- Experience with Excel at a minimum. Experience withexternal clinical forecasting systems(i.e. Signant Health)is a plus.
- Must have handson working experience in global IRT systems.
- Proven track record of effective collaboration with external providers.
- Ability to coordinate support for clinical sites; experience with infusionbased therapies required.
- Demonstrated ability to facilitate project team meetings enhance crossfunctional communication.
- Ability to work flexible business hours to communicate with global business partners.
- Ability to travel as needed.
What We Will Provide To You
- The base salary range for this role is $180500 $199500. The final compensation will be commensurate with such factors as relevant experience skillset internal equity and market factors.
- Avidity offers competitive compensation and benefits which include 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 which includes a variety of programming internally developed by and for Avidity employees opportunities for jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
Required Experience:
Director
Employment Type
Full-Time
