We are seeking a Clinical Development Lead (CDL) reporting to the Chief Medical Officer to oversee and drive strategic planning, execution, and oversight of clinical development programs across one or more assets. This role provides medical and scientific leadership to ensure the successful design, implementation, and interpretation of clinical studies, working cross-functionally to advance compounds from early development through regulatory approval.
The ideal candidate is a strategic thinker with a hands-on understanding of the operational complexities of drug development and is eager to bring therapies to patients with a sense of urgency.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
- Serve as the clinical lead on cross-functional development program teams to develop and execute the overall clinical development strategy for assigned programs, in collaboration with key stakeholders and leadership, while providing scientific and medical input into target product profiles, development plans, and lifecycle strategies.
- Lead the development of clinical trial design and strategies based on the scientific rationale and development and program objectives, including development of study protocols, investigator brochures, and clinical study reports.
- Partner closely with Clinical Operations to execute on clinical trials, including study execution, recruitment and enrollment, development of study specific management plans and materials, and data management activities.
- Collaborate with Program Management, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs to ensure high-quality study and program execution.
- Ensure internal study teams, investigators and site personnel, and external vendors are trained on clinical trial design and rationale, and provide support for data management activities, including development of case report forms, review of protocol deviations, and resolution issues.
- Support medical monitors in evaluating safety data, including review of safety reports, contribution to risk assessment and mitigation plans, and interfacing with investigators as applicable.
- Lead preparation for and serve as medical representative for Data Monitoring Committees (DMCs), Safety Review Committees (SRC), or similar safety data review boards.
- Contribute to development of regulatory submissions (e.g., IND/CTAs), participate in health authority agency interactions (e.g., FDA/EMA), and engage with thought leaders and investigators.
- Provide clinical insights to support business development, licensing, and due diligence activities.
- Drive a culture of scientific excellence, innovation, and collaboration.
- Ensure activities are executed in accordance with regulatory requirements, ICH/GCP guidances, and company standards.
Standout Skills for Impact:- Clinical Expertise: Deep experience in clinical trial design and ability to clearly articulate scientific concepts.
- Leadership: Proven cross-functional leadership driving alignment and results.
- Influence: Strong ability to build credibility and influence external stakeholders, including scientific and thought leaders.
- Communication: Excellent presentation and communication skills across diverse audiences.
- Execution: Translates strategy into effective, actionable plans and delivers with impact.
Qualifications and Experience: - MD, PhD, or PharmD in a relevant life sciences discipline
- Minimum 8-12+ years of experience in clinical research and drug development within biotech/pharma
- Demonstrated experience leading clinical programs and interacting with regulatory authorities, including successful submissions of IND/CTAs
- Strong understanding of clinical trial design, including endpoint development, patient selection criteria, statistical analyses, sponsor oversight responsibilities, and regulatory requirements.
- Experience across multiple phases of development
- Strategic thinking and decision-making ability.
- Excellent communication and presentation skills.
- Strong leadership and cross-functional collaboration capabilities.
- Ability to manage multiple priorities in a fast-paced environment.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$315,000-$370,000 USD
