Clinical Trial Lead (Sr. CTL/ AD)

Mediar Therapeutics is a clinical stage biotechnology company developing therapeutics to halt, or even reverse, fibrosis and restore long-term organ function. The platform and pipeline are based on an emerging class of novel targets- fibrotic mediators – that play key roles in modulating myofibroblast biology and the development of fibrosis chronically damaged organs. Mediar was founded by Mass General Brigham Ventures, Massachusetts General Hospital and Brigham & Women’s Hospital and has laboratory and office space in Boston.

We are seeking a Clinical Trial Lead who will lead and direct execution of clinical studies across multiple clinical programs. They are responsible for overseeing the coordination, management, and operational aspects of assigned clinical studies to secure the successful completion of projects within prescribed time frame and funding parameters. They are responsible for the planning, implementation and conduct of clinical trials.

The Sr. CTL will oversee some or all elements of clinical studies with oversight. The have solid knowledge of the processes involving clinical studies, a broad understanding of essential study documentation, be highly adaptable, solutions oriented, and can prioritize and manage timelines and key deliverables.

The Associate Director is additionally expected to provide leadership within the Clinical Operations department and make recommendations with regards to the strategic aspects of their assigned study(ies). They work cross-functionally to identify and evaluate issues, interprets data on complex issues, makes good business decisions and suggest and implement solutions. The Associate Director, with support from the Clinical Operations leadership, is accountable for ensuring that all project deliverables meet the corporate and department expectations.

Role Responsibilities (Sr. CTL):

• Participates in the internal cross-functional study team(s); Serve as key contact to other groups outside of Clinical Operations involved and contributing to the operational aspects of clinical trials
• Participates in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
• Manages external vendors, including CROs, central laboratories, and other external service providers, as necessary, from study start-up through final clinical study report
• Assists in the preparation and review of the Protocol, Informed Consent, Case Report Forms and associated completion guidelines, and other study documents
• Manages study timelines, budgets, and quality metrics in accordance with corporate objectives and goals
• Leads and oversees study activities from study startup through closeout
• Participates in the preparation and negotiation of clinical site and assigned CRO budgets and tracks variances
• Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Supports clinical study activities and ensures protocol and regulatory compliance
• Communicates study trends, issues, mitigation plans, and lessons learned to management
• Manages study-related quality metrics
• Manages multiple initiatives and shifts priorities within a small company environment
• Provides routine updates to project team on study status/issues
• Remote or Hybrid (2-3 days onsite/ week) dependent on location

In addition to the above, the Associate Director may:

• Participate as a member of the Clinical Operations team involved in defining the strategic direction of the clinical development path for various trials
• Lead clinical operations activities and process improvement initiatives; serving as the key individual to communicate updates to all team members involved
• Keep up to date with industry practice and communicates key message back to team and provides recommendations accordingly
• Able to present at departmental and interdepartmental meetings
• Be able to lead direct reports, and oversee the work of others including mentoring of staff on all assigned projects

Required Qualifications:

• Bachelor’s Degree.
• CTL: 6-8 years of experience in clinical development.
• AD: 8-10 years of experience in clinical development
• Prior employment at a biotech in similar role preferred.
• Experience managing complex schedules and priorities in dynamic environments.
• Ability to influence others and work independently and in a team environment.
• Driven and self-motivated with the ability to lead and facilitate priorities and activities across internal and external cross functional teams.
• Agility, to quickly adjust and navigate shifting priorities, demands and timelines.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.

Our Culture & Values

At Mediar, we foster a collaborative, mission-driven environment where every team member contributes to advancing transformative therapies for patients with fibrotic diseases. Our core values are Curiosity, Community, and Integrity. These values guide everything we do, from scientific innovation to how we work together as a team.

Equal Employment Opportunity

Mediar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status or any other classification protected under applicable law. Mediar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.