Associate Director, Clinical Operations, DMD

Location
San Diego, CA, United States
Posted
Feb 10, 2021
Ref
od6EefwV
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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 Associate Director Clinical Operations is responsible to lead cross functional Clinical teams to define study specifications and achieve study milestones through operational feasibility, budget and timeline estimates, operational accountability, and management of study deliverables. This role is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. This individual may be accountable for setting and managing operations across multiple studies in support of Avidity's Duchenne Muscular Dystrophy (DMD) program.

We are developing AOCs to treat the underlying cause of DMD. The oligonucleotides in our AOCs are designed to promote the skipping of specific exons to allow the production of the dystrophin gene product. In preclinical studies, we observed that treatment of an mdx mouse with an AOC caused a greater than 50-fold increase in exon skipping compared to an equimolar dose of the unconjugated oligonucleotide. We are focusing our initial efforts on the development of AOCs for mutations amenable to skipping Exon 44, Exon 45 and Exon 51 and we intend to conjugate these individual oligonucleotides to our proprietary mAb targeting TfR1.

Responsibilities
  • Lead a highly performing clinical development function. Ensures appropriate strategic topics are discussed and managed
  • Collaborate with core clinical team members to ensure that the program has a Clinical Development Plan (CDP) that meets the strategic objective of the asset plan and has been updated and approved by appropriate approval/governance bodies
  • Effectively collaborate in a highly matrixed organization
  • Develop and execute the clinical development plan (CDP) in conjunction with the lead physician, providing strategic and operational perspectives around study timelines, financials, key decision points, risk factors, study scenarios, etc.
  • Represent the clinical function on cross functional teams
  • Report on the status of the CDP and offer operational leadership to ensure key milestones are met in compliance with quality standards (including ICH, GCP, local regulations, and Avidity procedures)
  • Interface with key external stakeholders (KOL's, advocacy groups, partners etc.) as needed to understand the therapeutic landscape and leverage this knowledge for the benefit of the program
  • Provide oversight of individual studies and ongoing review to ensure adherence with key parameters (eg, time, cost, quality) of the clinical development plan
  • Accountable for operational delivery of all studies within the CDP through the program lifecycle (from planning, execution, data delivery and inspection planning and support activities)
  • Leverage operational expertise to develop an overall program level operations strategy that complements the indication, science and strategic intent of the CDP
  • Contribute to ongoing process improvement and department initiatives within the clinical function

Qualifications
  • Bachelor's Degree required; Advanced Degree preferred
  • 8+ years of industry experience within clinical project or program management
  • Knowledge of regulatory and compliance requirements for clinical research, including but not limited to US CFR, ICH, and GCPs
  • Experience in developing study budgets and forecasting and managing financial oversight
  • Team leadership experience within a cross functional matrix environment
  • Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills