Avidity Biosciences Careers

Description

Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Position Overview

The Sr. Dir./Director, Clinical Supplies will work in partnership with the regulatory, business, operational, clinical development, and technology areas to support the execution of clinical trials in clinical supply management. This includes management, in conjunction with CMC, of the planning/forecasting, packaging/labeling, distribution and destruction/return of clinical supplies for phase I-IV clinical trials in multi-national clinical studies. The Sr. Dir/Director will be responsible for the selection and implementation of the IRT (Interactive Response Technology), including drug resupply of investigative sites and IP-related cohort management, management of the IRT vendor(s) throughout the trial life cycle, and will be responsible for development and revisions of the Pharmacy Manual. This individual will successfully manage multiple projects simultaneously while adapting to changing project priorities. Instills, promotes, and maintains a culture of organizational excellence, and leads by example. 

Responsibilities

• Provide strategic and operational leadership for the design, development, and implementation of the clinical and ancillary supplies procurement and logistics strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials.  Represent supply chain and logistics on internal and external cross functional teams.  
• Manage, in conjunction with CMC, clinical supply (including ancillary supplies such as biopsy devices/needles, laboratory tubes, etc.) planning and forecasting for study protocols. 
• Serve as member of clinical drug supply team, as assigned.  
• Develop and maintain Pharmacy Binder (Pharmacy Manual plus logs and appendices) in collaboration with clinical operations, clinical development, and CMC.
• Responsible for authoring Study Drug sections in clinical protocols
• Interpret relevant protocol information to assist CMC with the development of packaging/labeling design and/or distribution strategy.  
• Coordinate the origination, proofing, and translation of clinical study labels, as required.  
• Work closely with and attend CMC meetings, as necessary, to ensure full collaboration and seamless communication regarding drug supply, expiry, labeling, timelines, etc.
• Support financial planning for clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline.  
• Communicate with drug depot to facilitate clinical trial drug supply delivery timelines with Clinical Operations, Clinical Development, Manufacturing, QA, and Regulatory Affairs, as required.  
• Prepare required documentation and assist internal and external stakeholders to facilitate activities for the import and export of clinical supplies to depots and study sites, as required.  
• Resolve issues involving distribution of clinical supplies, including US & International shipments.  
• Maintain close communications with all internal functional groups to ensure the adequate supply of clinical supplies to support first enrollment and throughout the duration of a clinical trial.  
• Responsible for selection and management of IRT vendor(s). Responsibilities include development of UAT plan, managing UAT with cross functional team members, issue escalation and working with internal and external key stakeholders (i.e., Unblinded teams, Investigative sites, Pharmacies, Drug Depots) to ensure proper supply module features and to resolve issues throughout the trial.
• Develop training materials related to pharmacy activities (Pharmacy Manual, IRT, etc.) including creation of presentations/slides for SIVs, IMs, etc., and serve as a liaison with site pharmacies
• Manage clinical supply complaints received from investigative sites and/or subsidiaries, and address supply replacement requests with support from Quality Assurance.  
• Monitor global clinical supply inventory (IRT and/or traditional studies) via tracking of specific milestone dates and adjusting drug distribution plan accordingly.  
• Monitor expiry dating for clinical study supplies.  Work with supply chain to ensure expiry dates are updated in the IRT as IMP shelf life is extended.
• Drive the project schedule and associated deliverables by working with internal/external stakeholders to ensure Sponsor and CRO expectations are met, and are delivered in accordance with the contract, trial protocol, ICH/GCP, GMP and applicable SOPs.  
• Coordinate procurement activities for comparator, other NIMP and/or ancillary supplies.  
• Participate in implementation of improvement initiative(s).  
• Serve as a resource for and interact with other functional areas to resolve clinical supply inventory, distribution, pharmacy and site issues. .
• In conjunction with CMC, identify and communicate any risks to clinical program timelines due to manufacturing delays.
• Ensure adherence to applicable regulations, including FDA, EMA, ICH, GCP, GMP and Avidity
• Effectively collaborate in a highly matrixed organization.
• Perform other duties as required. 
  • Qualifications
• Bachelor’s degree Life/Health Sciences; Master’s degree a plus 
• Minimum of 10 years of experience in pharmaceutical / biotech  
• Minimum 7 years in a management role within Clinical Supplies 
• Working knowledge of Clinical Operations
• Team leadership experience within a cross functional matrix environment
• Proven track record of effective collaboration with external logistics providers.
• Excellent organization, communication, and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.