Director/Senior Director Clinical Development

$220,000 - $355,000/Yr

Avidity Biosciences - San Diego, CA

Full-time - Senior

San Diego, CA

Professional, Scientific, and Technical Services

About the position

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. This position will work with key internal and external stakeholders to contribute to the development and execution of clinical development plans (CDPs) and clinical trials. The role may serve as trial clinical lead for one or more clinical trials. In collaboration with the Program Clinical Lead and cross-functional program team members, this position will contribute to the overall development strategy, lead the development of clinical protocols, analyze and interpret safety and efficacy data, and contribute to regulatory submissions, publications, and presentations. They will serve as a member of the development subteam, providing guidance and direction to the team to ensure successful achievement of program goals and milestones and to ensure all activities occur in compliance with the appropriate regulations and ICH/GCP. As appropriate with background and experience, this position may also be responsible for providing medical support including oversight of CRO medical monitoring during study conduct. The Director/Senior Director will provide scientific/medical input into the design of the CDP for investigational products in all phases of development, contribute to the development of clinical content including protocols, amendments, investigator brochures, informed consent forms, clinical study reports, statistical analysis plans, study manuals, regulatory submissions, and publications associated with clinical trials. They will collaborate closely with the clinical study team to ensure data quality and patient safety, including site selection, ongoing review of clinical data including protocol deviations, and support of clinical database and central lab build, providing scientific/medical input and training as needed. Additionally, they will analyze, interpret, and present results of clinical studies to include manuscripts, abstracts, and posters, while maintaining scientific and clinical knowledge in the relevant therapeutic and disease area(s).

Responsibilities

• Work with key internal and external stakeholders to develop and execute clinical development plans (CDPs) and clinical trials.
• Serve as trial clinical lead for one or more clinical trials.
• Collaborate with the Program Clinical Lead and cross-functional program team members to contribute to the overall development strategy.
• Lead the development of clinical protocols and analyze safety and efficacy data.
• Contribute to regulatory submissions, publications, and presentations.
• Provide guidance and direction to the development subteam to ensure successful achievement of program goals and milestones.
• Ensure compliance with appropriate regulations and ICH/GCP during all activities.
• Provide scientific/medical input into the design of the CDP for investigational products.
• Develop and implement study protocols in conjunction with the clinical development team.
• Collaborate closely with the clinical study team to ensure data quality and patient safety.
• Analyze, interpret, and present results of clinical studies, including manuscripts, abstracts, and posters.
• Communicate potential issues or risks to management and relevant functions in a timely manner.
• Contribute to key cross-functional and clinical meetings.
• Identify potential collaborators and investigators.
• Build strong relationships with KOLs and patient advocacy groups; make scientific presentations at advisory boards and key scientific meetings.

Requirements

• PhD, PharmD or MD required.
• Minimum of 6 years of experience in pharmaceutical/biotech in clinical sciences and clinical drug development.
• Rare disease experience is a plus.
• Ability to assimilate technical and scientific information and proficient at data interpretation.
• Knowledge of clinical trial design and in-depth understanding of Phase 1 through 4 drug development.
• Knowledge of FDA and EMEA guidelines.
• Experience writing all types of clinical & regulatory documents and familiarity with registration dossiers for worldwide use.
• Skilled in use of MS WORD, Excel, and Power Point.
• Excellent interpersonal, communication, and presentation skills (written and verbal).
• Demonstrate strong organizational skills, including the ability to prioritize personal workload.
• Supervisory experience and ability to guide, train, supervise and prioritize workload of direct reports.
• Ability to work well in a deadline-driven environment.
• Capable of supporting multiple projects simultaneously.
• Ability to work on cross-functional teams.

Nice-to-haves

• Experience in rare disease clinical development.
• Familiarity with advanced statistical analysis techniques.

Benefits

• Competitive compensation and benefits including annual and spot bonuses, stock options, and RSUs.
• 401(k) with employer match.
• Comprehensive wellness program including medical, dental, vision, and LTD coverage.
• Four weeks of time off.
• Commitment to learning and development with various programming and education reimbursement.