Executive Director, Clinical Development

Location
San Diego, California
Posted
Jul 28, 2021
Ref
o3XLefwJ
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
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.

Job Summary

This position will serve as the Global Development Lead (GDL) for one or more of Avidity’s neuromuscular clinical programs.  The GDL is responsible for the design and successful implementation of the Clinical Development plan (CDP). This position will lead the cross-functional program team, and collaborate with project management, clinical operations, regulatory, data management, clinical pharmacology, medical affairs, research, and other groups as appropriate for execution of the CDP.  They will coordinate and monitor the clinical studies ensuring compliance with ICH/GCP and federal regulations. They will also be responsible for the review of efficacy and safety data, including dissemination of study results and related publications.  They will participate in regulatory interactions and contribute to building relationships with KOLs.

Essential Duties and Responsibilities
  • Work with key internal and external stakeholders to lead the design and implementation of the CDP
  • Design and draft protocol synopses, clinical trial protocols and protocol amendments to meet the CDP objectives.
  • Oversees and resolves operational aspects of clinical studies in collaboration with study teams
  • Leads the cross-functional team implementing the CDP and develops strategies to identify, monitor and resolve clinical program issues and risks
  • Contribute to IBs, regulatory documents, CSRs  and publications associated with the clinical trials
  • Reviews, monitors, and interprets safety and efficacy data within clinical program
  • Provides medical monitoring oversight (as applicable)
  • Sets strategy for Advisory Boards, and builds strong relationships with KOLs
  • Provides scientific leadership for regulatory document creation (e.g. briefing documents, IND, NDAs)
  • Interface with US/international regulatory authorities, as appropriate, and assist in the compilation of submissions and responses to inquires
  • Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s)
  • Communicate to management and relevant functions any potential issues or risks (e.g., changes or significant risks to the Clinical Development Plan, new safety concerns) in a timely manner.
  • Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
  • Act as the clinical representative in variety of cross-functional teams
  • Provides mentorship and guidance to clinical scientists
Qualifications
  • Medical Doctor (M.D.), PhD or PharmD required
  • 15+ years’ experience of relevant pharmaceutical/biotechnology industry clinical development experience; or equivalent
  • Experience in rare diseases strongly preferred
  •  
  • In depth knowledge of drug development process and oversight of clinical trials
  • Experience with global clinical studies
  • Experience leading clinical sections of regulatory documents and attend meetings with FDA and EMA
  • Demonstrated ability to make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management
  • Experience optimizing extensive knowledge of the clinical development process and strong relationships with team members, colleagues, and internal and external stakeholders to achieve results
  • Excellent communication (oral and written), analytical, organizational, and project management skills
  • Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders
  • Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment