Vice President, Clinical Development – Neuromuscular
- Employer
- Avidity Biosciences
- Location
- San Diego, California
- Start date
- Sep 19, 2024
View more categoriesView less categories
- Discipline
- Clinical, Clinical Development, Clinical Research
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
- 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.
- 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
- 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
- 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.
Company
Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.
Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.
We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.
- Website
- http://www.aviditybiosciences.com/
- Phone
- 858-401-7900
- Location
-
10578 Science Center Drive
Suite 125
San Diego
California
92121
US
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