Executive Director Clinical Supply Chain
Executive Director Clinical Supply Chain
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Job Description
Description
Job Title:
Executive Director Clinical Supply Chain
Location:
Hybrid
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
TD&O
7625Q22429
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 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 in San Diego CA. For more information about our AOC platform clinical development pipeline and people please visit 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 Aviditys clinical supply strategy. The individual will report to the Vice President Global Supply Chain and be accountable to manage supply across all of Aviditys 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 Aviditys 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 Aviditys 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 Aviditys S&OP process.
- Manage implementation of Aviditys 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.
- Ensureclinical drug inventory levels are maintained in accordance with study plans and that inventory is strategically positioned in accordance with enrolment projections.
- Provide support for Aviditys pharmacy manuals and investigator brochures as required.
- Strengthen procedural elements of the clinical supply team including review development and maintenance ofClinical Supply SOPs.
- Ensure accurate and timely communication to Program teams of any clinical supply risks. Work crossfunctionally 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 appropriateregional labeling strategy to make optimal use of limited clinical inventory.
- Monitor pharmaceutical preparation and dose administration questions from clinical investigator sites and develop Aviditys response strategy.
- Assist in pullforward of Aviditys 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
Bachelors 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 thirdparty CMOs manufacturing cGMP clinical supplies (labeling kitting clinical supply serialization etc.
Experience with dose calculations for weightbased 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 Aviditys shipping & logistics team.
Proven track record of effective collaboration with external providers.
Excellent communication and interpersonal skills and the ability to facilitate constructive expedient problemsolving.
Ability to travel as needed.
What We Will Provide to You:
The base salary range for this role is $270750 $300000. 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
#LIDNI
Required Experience:
Director
Employment Type
Full-Time
