Associate Director, Clinical Operations at Merida Biosciences

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jun, 26

Salary

240000.0

Posted On

04 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Phase I-III Trials, CRO Management, Vendor Management, Protocol Review, Feasibility Assessments, Risk Mitigation, Timeline Development, Budget Development, Cross-functional Partnering, ICH-GCP Compliance, Regulatory Requirements, Data Cleaning, Study Start-up, Study Close-out, Mentoring

Industry

Description

Description At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking an experienced and motivated Associate Director, Clinical Operations to play a key role in the planning, execution, and oversight of our clinical trials. Reporting to the Senior Director of Clinical Operations, this individual will contribute strategically and operationally across one or more clinical programs and help drive study execution from start-up through close-out. This is an exciting opportunity to join a small biotech environment where you will have meaningful impact, broad visibility, and the ability to shape processes as we scale. Key Responsibilities Independently lead and oversee the operational execution of Phase I–III clinical trials in collaboration with cross-functional partners and external vendors. Serve as the clinical operations lead for assigned studies and program(s), ensuring timelines, budgets, and quality standards are met. Independently manage CROs and other vendors, including oversight of performance, deliverables, and issue resolution. Contribute to study planning activities, including protocol review, feasibility assessments, site selection strategy, and risk mitigation planning. Lead timeline and budget development for assigned studies and is responsible for delivery to both. Partner cross-functionally with Clinical Development, Regulatory, Data Management, Biostatistics, Safety, Quality, and CMC to ensure aligned execution. Disseminate clinical trial communications to all functional groups, inclusive of key trial performance information, enrollment, and related metrics. Monitor study progress through metrics and KPIs; proactively identify and mitigate risks. Develop and implement robust contingency and risk management plans to solve complex issues that may impact study milestones. Oversight of study team and site training, inclusive of investigator meeting planning and presentations. Oversight of study start-up, study management, data cleaning, and study closeout activities. Participate in clinical data review for assigned trials. May interact with Senior Management to report on progress of milestones. Ensure trials are conducted in compliance with ICH-GCP, company SOPs, and applicable regulatory requirements. Support inspection readiness activities and participate in audits and regulatory inspections as needed. Contribute to the development and refinement of clinical operations processes and infrastructure as the company grows. Mentor junior team members or consultants, as appropriate. Requirements Qualifications Bachelor’s degree in Health or Life Sciences required; advanced degree preferred. 7+ years of clinical operations experience in biotech, pharma, or CRO settings, with increasing levels of responsibility. Demonstrated experience leading global clinical trials. Early phase/Phase 1 trial experience required. Strong CRO and vendor management experience. Solid understanding of ICH-GCP guidelines and regulatory requirements. Experience in a small or emerging biotech environment strongly preferred. Excellent organizational, communication, and problem-solving skills. Ability to operate both strategically and tactically in a fast-paced, evolving environment. Strong leadership presence with the ability to influence cross-functional stakeholders. Ability to travel is required. Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Associate Director level we target $200,000 to $240,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Responsibilities

This role involves independently leading and overseeing the operational execution of Phase I-III clinical trials, ensuring timelines, budgets, and quality standards are met in collaboration with cross-functional teams and vendors. The individual will also manage CROs, contribute to study planning, monitor progress using metrics, and ensure compliance with regulatory requirements.