Senior Director, Clinical Development

Senior Director, Clinical Development role s listing references Avidity Biosciences and describes responsibilities, qualifications, and benefits associated with the role.

Location:

Remote. Type:
Full time, Exempt. Department:
Clinical Development. Finance
-W52449-BF.

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit  and engage with us on Linked In and Twitter.

This role offers an exciting opportunity to be a key contributor to the planning and execution of clinical development plans and clinical trials in rare diseases. As a Senior Director in Clinical Development, you'll collaborate closely with cross-functional teams and the Global Development Lead to shape development strategies, design study protocols, and analyze safety and efficacy data. You’ll play a central role in driving regulatory submissions, publications, and presentations, while ensuring trials are conducted in alignment with ICH/GCP guidelines.

This position also includes providing medical oversight during study conduct, including supporting CRO medical monitors. If you’re passionate about advancing innovative therapies and thrive in a collaborative, fast-paced matrix environment, this role provides a meaningful way to make an impact.

• Provide scientific/medical thought leadership into the design of the CDP for investigational products in all phases of development and 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
• Manage the process for developing and implementing study protocols in conjunction with the Clinical Development team
• Collaborate closely with clinical study team to ensure data quality and patient safety, including site selection, ongoing review of clinical data including protocol deviations, support of clinical database and central lab build, providing scientific/medical input and training as needed
• Analyze, interpret, and present results of clinical studies to include manuscripts, abstracts, and posters
• 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
• Identify potential collaborators and investigators and contribute to key cross-functional and clinical meetings (e.g., investigator meetings, ad hoc meetings, scientific focus, or steering committee meetings
• Contributes to 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
• Consistently comply with regulations, ICH/GCP and company SOPs
• Collaborates closely with study investigators on clinical trial eligibility and subject and patient safety issues, as well as site staff to ensure quality in trial execution
• Serves as a medical monitor and provides oversight of CRO medical monitors
• Provides safety oversight during clinical programs and makes recommendations based on safety findings to team, as needed and in collaboration with drug safety and pharmacovigilance team for safety reporting
• Reviews, interprets, and approves safety data in clinical study reports, regulatory documents and submissions related to clinical trials (e.g., IND and NDA)

• Ability to assimilate technical and scientific information and proficient at data interpretation
• 10+ years of relevant experience in a Clinical Development setting, including 2-3 years of experience within a Biotech or Bio Pharma company required. Experience with rare diseases is a plus.
• Medical Degree or equivalent required.
• 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.
• Excellent interpersonal, communication, presentation skills…