Director, Clinical Research (Lingo)

The Opportunity

We are seeking an experienced Director of Clinical Research to lead the strategic planning, execution, and oversight of Lingo's clinical research programs. You will be responsible for applying clinical best practices, regulations, and quality standards for successful planning and execution of a clinical research program that includes internal studies, investigator-initiated studies, real world evidence and studies done with external partners to evaluate safety and efficacy. This position will be required to manage multiple projects simultaneously and meet targeted timelines while strategizing for issue resolution and study execution. You will need to partner and develop working relationships with new clinical sites, vendors, CROs and KOLs.

What You'll Work On

• Direct the design, planning, development, monitoring and execution of all clinical research activities within the Lingo Division.
• Manage a clinical study team that may include Clinical Research Associates, Senior Clinical Research Associates, and Clinical Study Assistants.
• Provide guidance, team building, and professional development for direct reports.
• Evaluate and interpret clinical research data to ensure timely, accurate analysis and interpretation.
• Contribute to the development of strategic goals and the preparation of clinically and scientifically sound publications, manuscripts, abstracts, and presentations.
• Demonstrate strong leadership and coaching skills to build effective relationships within the team and across the Division.
• Manage the development of clinical trial protocols, final reports, clinical brochures, and the negotiation and execution of clinical site agreements.
• Prepare Clinical Project Charters outlining timelines, budgets, and personnel requirements, ensuring projects operate within approved scope and budget.
• Align functional goals with the Division's long-term business needs and strategic objectives.
• Maintain, promote, and model social, ethical, and organizational norms and ensure adherence to compliance standards and ethical principles.
• Collaborate with internal (e.g., Product, Marketing, Medical Affairs, Regulatory, Quality, and Legal) and external (e.g., Principal Investigators, Key Opinion Leaders) partners to execute strategic initiatives.

Required Qualifications

• Bachelor's degree in a related scientific or medical field required
• Master's degree, PhD, MD, or DO strongly preferred
• Minimum of 10 years of related clinical research experience
• Demonstrated experience designing and conducting randomized controlled trials
• Strong understanding of the scientific method and its application to well controlled clinical evaluations
• Proven leadership experience managing and developing clinical research teams

Skills & Competencies

• Deep knowledge and expertise in clinical research design research and execution
• Content expertise in the metabolic health space
• Strong project management, budgeting, and organizational skills
• Excellent written, verbal, and presentation skills
• Ability to communicate effectively with cross-functional stakeholders and external regulatory agencies
• Strong collaborative skills and experience working in matrixed organizations
• Strategic thinker with the ability to manage multiple priorities in a fast-paced environment