Sr. Clinical Development Lead

Location: Remote – East Coast preference

About the Company

A public late-stage biotech developing breakthrough receptor antagonist therapies targeting rare, life-threatening disorders, with locations in Europe and the US (Boston).

About the Role

Join as an experienced and driven individual contributor who reports directly into the Head of Clinical Development. Drive end-to-end execution for high-priority rare disease programs.

Responsibilities

• Develop and define short- and long-term objectives aligned with global clinical strategies, and communicate these effectively with clinical staff.
• Provide strategic leadership to phase 1-3 development programs and oversee global clinical trials/trial teams on assigned programs.
• Lead study protocol development, oversee study execution, and final study report development.
• Identify and address safety issues reported within assigned programs and develop appropriate mitigation strategies.
• Participate in Clinical Team and Operations meetings, including discussion on program budgets and resource allocation.
• Evaluate emerging medical and scientific data within therapeutic areas and design clinical strategies to support product development.
• Collaborate with cross-functional teams, including nonclinical and business development, to explore new therapeutic targets and indications.
• Present at academic congresses, investigator meetings, and advisory meetings.
• Contribute to regulatory submissions by authoring and reviewing clinical sections of submission dossiers as a medical expert, ensuring alignment with global strategies.
• Conduct due diligence by evaluating clinical strategies and development plans of external partners.
• Engage with external professional bodies to identify and develop key opinion leaders in assigned therapeutic areas.
• Stay current with scientific advancements and provide training and guidance to team members as appropriate.

Requirements

• MD, preferably with a relevant specialization (e.g., immunology, hematology, nephrology).
• 5+ years of experience in clinical research, preferably within industry, especially in rare diseases.
• Regulatory experience, especially with successful IND and/or NDA submission experience preferred.
• Excellent written and oral communication skills. English is the company language.

Pay

$260K – $290K