Director, Clinical Operations (Unblinded)
Director, Clinical Operations (Unblinded)
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Job Description
Description
Job Title:
Director Clinical Operations (Unblinded)
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Clinical Operations
7525Q22414
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
The Director Clinical Operations (Unblinded) is a senior leader responsible for overseeing unblinded activities across multiple clinical studies within Aviditys programs. This role provides strategic leadership mentorship and operational oversight to drive excellence in clinical trial execution while ensuring compliance with GCP and regulatory guidelines. The Director plays a key role in shaping and advancing Clinical Operations (CO) strategies process improvements and organizational development. This role requires close collaboration with CO CMC Supply Chain and external vendors to ensure the delivery of complex global studies.
Additionally this position is responsible for line management providing training support and mentoring for direct reports to ensure their professional growth and successful execution of assigned responsibilities.
What You Will Contribute
- Lead the unblinded Clinical Operations team in the planning and execution of clinical studies ensuring alignment with company objectives and regulatory requirements.
- Oversee study execution in collaboration with CROs and vendors ensuring adherence to scope timelines budget and quality standards.
- Provide proper oversight of study CROs and vendors by reviewing unblinded monitoring visit reports identifying and addressing issues and trends and ensuring timely resolution.
- Develop review and/or consult on reports and clinical trial documents such as informed consent clinical protocols clinical monitoring plans etc.
- Serve as an escalation point for unblinded study team members internally CROs and vendors.
- Ensure the CRO is maintaining an inspection ready Unblinded Trial Master File (uTMF).
- Collaborate with CROs on studyspecific training for study teams and study sites.
- Conduct comonitoring visits with unblinded CRAs (uCRAs) as required.
- Facilitate and support unblinded Sponsor oversight visits as required.
- In conjunction with CMC support planning and forecasting for study protocols
- In conjunction with Supply Chain develop requestforproposals documents and solicit and evaluate bids; lead contracting process with selected vendors collaborating with relevant departments such as Legal and Finance.
- Collaborate with Clinical Operations Clinical Development and CMC to support the development and maintenance of the Pharmacy Binder (Pharmacy Manual plus logs and appendices).
- Support Clinical Supply in proofing and translation of clinical study labels as required.
- Work closely with CMC and attend CMC meetings as necessary to ensure full collaboration and seamless communication regarding drug supply expiry labeling timelines etc.
- Communicate with CMC to facilitate clinical trial drug supply at drug depot(s) and clinical sites.
- Monitor global clinical supply inventory (IRT and/or traditional studies) via tracking of specific milestone dates and adjusting drug distribution plans accordingly.
- Monitor expiry dating for clinical study supplies and work with Supply Chain to ensure expiry dates are updated in the IRT as IMP shelf life is extended.
- Coordinate procurement activities for pharmacy ancillary supplies as required.
- Serve as a resource for and interact with other functional areas to resolve clinical supply inventory distribution pharmacy and site issues.
- In conjunction with CMC identify and communicateanyriskstoclinical programtimelines due to manufacturing delays.
- Representthe unblinded clinical function on cross functional teams
- Contribute to ongoing process improvement and department initiatives withinthe clinical function
- Effectively collaborate in a highly matrixed organization
- May oversee management of Independent Data Monitoring Committees
- Allocate resources effectively to support clinical programs and ensure the timely completion of deliverables.
- Identify and mitigate risks related to budget timelines and resources.
- Recruit mentor and manage a high performing unblinded Clinical Operations team.
- Provide ongoing training and professional development opportunities to team members.
- Conduct performance evaluations and establish career development plans for direct reports.
- Act as the primary point of contact for unblinded Clinical Operations within the company liaising with internal and external stakeholders including investigators key opinion leaders (KOLs) and regulatory authorities.
- Represent the company at industry conferences meetings and other events as needed.
What We Seek
- Bachelors Degree required; Advanced Degree preferred.
- Minimum of 12 years of experience in Clinical Operations with at least 8 years in a leadership role within a biotech or pharmaceutical company.
- Extensive knowledge of clinical trial design management and regulatory requirements including US CFR ICH guidelines and GCPs.
- Proven experience in developing study budgets forecasting and managing financial oversight.
- Experience in developing and managing study timelines.
- Proven track record of managing unblinded study tasks and teams including oversight of investigational product handling drug accountability and pharmacy operations.
- Demonstrated experience collaborating with Clinical Supply and CMC teams to support packaging labeling distribution and expiry management activities.
- Strong background in vendor selection and oversight with specific experience managing CROs IRT vendors and other thirdparty providers.
- Technical proficiency with clinical systems particularly IRT platforms as well as familiarity with CTMS TMF and document tracking tools.
- Specialized experience in managing complex rare disease neuromuscular or cardiac clinical trials
- Strong initiative and attention to detail with the ability to thrive in a fastpaced environment and proactively prioritize tasks.
- Ability to work effectively within an agile cohesive teambased structure.
- Demonstrated success in managing complex projects including the selection and oversight of multiple study vendors CROs and clinical study teams with a track record of delivering results on time and within budget.
- Proven team leadership experience in a crossfunctional matrix environment.
- Excellent communication (oral and written) teamwork organizational interpersonal and problemsolving skills.
- Willingness and ability to travel globally as required including attendance at conferences site visits team meetings etc.
What We Will Provide To You
The base salary range for this role is $218500 $241500. 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:
#LIDNI
Required Experience:
Director
Employment Type
Full-Time
