Vice President, Clinical Development - Neuromuscular

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Job 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. Job Summary: Avidity is seeking a visionary Vice President of Clinical Development to lead the clinical strategy and execution of rare neuromuscular programs. Reporting to the Head of Clinical Development, the Vice President of Clinical Development will be a key member of the clinical development leadership team, playing a pivotal role in the design, execution, and oversight of multiple programs within the neuromuscular franchise. The role requires a strategic thinker with a deep understanding of drug development and clinical research, particularly in the field of neuromuscular diseases. The successful candidate will play a pivotal role in providing leadership, supervision, coordination, mentoring, career development, and performance management for the clinical development staff. This position will be viewed as a strategic partner to the Head of Clinical Development, helping to determine and shape strategy and standards of operational excellence and implementation across clinical development, driving the execution of clinical trials, and advancing the pipeline of novel therapies for rare neuromuscular diseases.Essential Duties and Responsibilities:

• Provide strategic leadership in the design and implementation of the Clinical Development Plan (CDP), ensuring it aligns with corporate objectives and regulatory requirements. Influence key decisions that drive the overall neurology portfolio.
• Collaborate closely with the Global Program Head and serve as a core member of the senior leadership team responsible for overall program oversight, including strategy development, launch readiness, and life-cycle management.
• Lead and direct cross-functional teams in executing clinical development activities, including overseeing the development subteams. Develop high-level strategies to proactively identify, monitor, and mitigate program issues and risks.
• Foster strong cross-functional collaboration with senior leaders across R&D, regulatory affairs, medical affairs, and commercial. Drive effective communication across functions and teams to ensure timely, strategic decision-making and comprehensive assessments.
• Lead high-level communication and decision-making by identifying and addressing potential risks and issues (e.g., significant changes to the CDP or emerging safety concerns) with executive management and relevant functions in a proactive and timely manner.
• Contribute to the development of regulatory strategies for neuromuscular programs. Provide expert scientific and medical input for the creation of key regulatory documents (e.g., briefing documents, INDs, BLAs) and participate in interactions with regulatory agencies to ensure successful approvals.
• Supervise the development of clinical trial protocols and amendments, guiding them to successful execution.
• Provide strategic oversight and medical guidance on clinical studies, including safety monitoring and interpretation of safety and efficacy data. Ensure that clinical trials are conducted to the highest scientific and ethical standards.
• Contribute and provide oversight to the development and review of critical study documents, including the Investigator Brochure, Data Monitoring Committee charters, clinical study reports, informed consent forms, statistical analysis plans, study manuals, and associated publications.
• Establish and cultivate strong relationships with key opinion leaders (KOLs), patient advocacy groups, investigators, and clinical research organizations. Set and lead strategies for Advisory Boards and represent the company in scientific presentations at key meetings and committees.
• Provide leadership, mentorship, and direct supervision to clinical scientists and study clinical leads. Promote a culture of excellence, fostering the growth and development of the clinical team and preparing future leaders within the organization.
• Stay at the forefront of scientific knowledge in neurology and related therapeutic areas. Leverage insights into emerging trends and competitive landscapes to guide the clinical program's direction and ensure its relevance in a rapidly evolving field.
• Ensure rigorous compliance with SOPs, ICH, GCP, and all national and international regulatory requirements. Oversee adherence to these standards across all clinical development activities to maintain the integrity and success of the clinical program.

Qualifications:

• Medical degree in neurology required
• Minimum of 15 years of experience in clinical development within the biopharmaceutical industry, with a focus on neurology and rare diseases, experience in neuromuscular preferred
• Proven track record of leading global clinical development programs, including rare indications, from Phase I-III to regulatory approval
• Deep understanding of clinical trial design, execution, and regulatory requirements
• Significant management experience, including direct oversight of teams, building and scaling clinical development teams, and effectively collaborating with commercial and research functions
• Proven ability to lead a portfolio of programs at different clinical stages, with demonstrated experience in strategic decision-making and execution in a fast-paced environment
• Broad knowledge of industry compliance requirements in the USA and EU, including a strong understanding of clinical trial strategies, regulatory pathways, and the medical information process
• Strong leadership skills with the ability to inspire and motivate cross-functional teams to achieve ambitious goals, while maintaining a strategic focus and attention to detail
• Strategic thinker with a keen analytical mindset, able to translate complex data into actionable insights that drive program success
• Exceptional communication, presentation, and interpersonal skills, with the ability to effectively engage and influence internal and external stakeholders at all levels
• Ability to work collaboratively in a matrixed team environment, fostering strong relationships across the organization and with external partners
• A self-starter with a hands-on approach to duties, and the ability to adapt to evolving priorities and challenges in a dynamic, fast-paced environment

Benefits of the Opportunity:

• Great management team who are all very experienced in developing and commercializing drugs
• Platform is first-in-class technology of antibody-oligonucleotide conjugates - able to effectively deliver oligonucleotides to tissues other than the liver, which has not previously been possible
• Already shown proof-of-mechanism with all three clinical stage programs (DM1, FSHD and DMD amenable to exon 44 skipping)
• Rare cardiac targets heading towards IND
• Very well capitalized

What We will Provide to You:

• The base salary range for this role is $378,000-$417,800. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

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