Apply for this job now

Senior / Executive Director Clinical Development

Location
San Diego, California
Job Type
Permanent
Posted
14 Jul 2022
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 Project Team Lead (PTL) and may also serve as the Clinical Lead for one or more of Avidity s neuromuscular clinical programs. The role will be responsible for the leading the design and successful implementation of the Clinical Development Plan (CDP), collaborating closely with the Program Manager (PM) and leading the cross-functional program team. The PTL in collaboration with the PM will drive development of strategies to identify, monitor and mitigate program level issues and risks that effect execution of the CDP and for ensuring timely communication to the program team and management. The PTL will be responsible for leading the design of clinical trials and development of protocols to meet the CDP objectives and for contributing to key regulatory documents and study level documents including the review and dissemination of study results and related publications.

Essential Duties and Responsibilities
  • Work with key internal and external stakeholders to lead the design and implementation of the CDP and the design of clinical trials to meet the objectives of the CDP
  • Leads the cross-functional team implementing the CDP and develops strategies to identify, monitor and resolve program issues and risks
  • Play a key role in communicating across lines and functions to facilitate timely and effective decision-making and to identify key questions to ensure robust assessments
  • 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.
  • Provide scientific input and strategy for regulatory document creation (briefing documents, IND, NDAs) and participate in regulatory interactions
  • Develop or oversee the development of clinical trial protocols and protocol amendments
  • Contribute to study documents to include Investigator Brochure, Data Monitoring Committee charters, clinical study reports, informed consent forms, statistical analysis plans, study manuals and publications associated with the clinical trials
  • Reviews, monitors, and interprets safety and efficacy data within clinical program
  • Sets strategy for Advisory Boards, and builds strong relationships with KOLs and patient advocacy groups; make scientific presentations at advisory boards, key scientific meetings and external committee meetings
  • Maintain scientific knowledge in relevant therapeutic disease areas
  • Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
Qualifications
  • Medical Doctor (M.D.), PhD or PharmD required
  • 15+ years experience of relevant pharmaceutical/biotechnology industry with five or more years of direct experience leading global clinical development programs from Phase 1-3; or equivalent
  • Experience in rare diseases strongly preferred
  • Strong leadership skills and able to influence and collaborate with peers and team members without direct line management
  • Experience with late stage development and NDA a plus
  • In depth knowledge of drug development process and oversight of clinical trials
  • 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
Apply for this job now

Details

  • Job Reference: 658126248-2
  • Date Posted: 14 July 2022
  • Recruiter: Avidity Biosciences
  • Location: San Diego, California
  • Salary: On Application
  • Sector: Executive Positions
  • Job Type: Permanent