Director, Clinical Development
Director, Clinical Development
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Job Description
Description
Job Title:
Director Clinical Development
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Clinical Development
2201W52449BF
Profoundly Improve Peoples lives by Revolutionizing the Delivery of RNA Therapeutics
At Avidity Biosciences we are passionate about the impact of every employee in realizing our vision of improving peoples 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 solutionoriented 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.
Avidity Biosciences Inc.s mission is to profoundly improve peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visit and engage with us on LinkedIn and X.
The Opportunity
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. Role may serve as trial clinical lead for one or more clinical trials. In collaboration with the Program Clinical Lead and crossfunctional 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 developmentsubteam 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.
What You Will Contribute
- Provide scientific/medical input into the design of the CDP for investigational products in all phases of development
- Provide scientific/medical input 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
- Responsible 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 CDP new safety concerns) in a timely manner
- Contribute to key crossfunctional and clinical meetings (e.g. investigator meetings ad hoc meetings scientific focus or steering committee meetings)
- Identify potential collaborators and investigators
- 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
- Perform other duties as required
- This position may also have the following responsibilities as appropriate with training and background (MD)
- 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 medical monitor and/or 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)
What We Seek
- PhD PharmD or MD required
- Minimum of 6 years of experience in pharmaceutical/ biotech in clinical sciences or clinical drug development
- Rare disease experience a plus.
- Ability to assimilate technical and scientific information and proficient at data interpretation and presentation to internal and external stakeholders.
- Knowledge of clinical trial design (Phase 14); particularly labelenabling trials.
- Skilled in all phases of clinical trial execution ie study startup to closeout
- Experience engaging clinical investigators and collaborating with clinical operations to deliver on assigned studies
- Knowledge of FDA and EMEA guidelines.
- Experience authoring responses to queries from Regulatory Authorities and clinical sections of regulatory documents and familiarity with product registration dossiers/BLA filings.
- 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.
- Ability to work well in a deadlinedriven environment.
- Capable of supporting multiple projects simultaneously.
- Ability to work on crossfunctional teams or work well within a matrix environment.
What We Will Provide To You
The base salary range for this role is $228k $252k. 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 include 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
Required Experience:
Director
Employment Type
Full-Time
