Associate Director, Clinical Operations, FSHD

Location
San Diego, California
Posted
Apr 29, 2021
Ref
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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 Facioscapulohumeral Muscular Dystrophy (FSHD) program.

FSHD is one of the most common forms of muscular dystrophy with onset typically in teens and young adults. FSHD is caused by aberrant expression of a gene, double homeobox 4 (DUX4), in adult skeletal muscle and is characterized by progressive skeletal muscle loss. Our therapeutic strategy in FSHD is to use an AOC based on our proprietary mAb targeting TfR1 to deliver an siRNA targeted to the DUX4 mRNA.

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