Remote Global Clinical Lead, Late-Phase Trials

Actalent; Lexington (MA); Remote; USD 179,000 - 207,000; Full time

Job summary

Actalent in Lexington, MA is seeking a Clinical Development Lead to define short- and long-term objectives aligned with global clinical strategies. You will provide strategic leadership for phase 1-3 development programs and oversee global trials, protocol development, execution, and final reports.

This contract role is remote, supporting Eastern or Central Time, with approximately 25% travel. It offers long-term opportunity to own global late-phase programs from a clinical development

Qualifications

• 7+ years of experience in clinical research, preferably within the industry and in rare diseases.
• Regulatory experience, including successful IND and/or NDA submission.
• Excellent written and oral communication skills in English.

Responsibilities

• Develop objectives aligned with global clinical strategies and communicate with clinical staff.
• Provide strategic leadership to phase 1-3 programs and oversee global clinical trials/trial teams.
• Lead protocol development, oversee execution, and develop final study reports.
• Identify and address safety issues within programs with mitigation strategies.
• Participate in Clinical Team and Operations meetings, discussing budgets and resources.
• Evaluate emerging medical and scientific data to design clinical strategies.
• Collaborate with cross-functional teams to explore new therapeutic targets.
• Present at academic congresses, investigator meetings, and advisory meetings.
• Contribute to regulatory submissions by authoring and reviewing clinical sections of submission dossiers.
• Conduct due diligence by evaluating clinical strategies and development plans of external partners.
• Engage with external professional bodies to develop key opinion leaders in therapeutic areas.
• Stay current with scientific advancements, providing training and guidance to team members.

Skills

Clinical research

Regulatory experience

English proficiency

Job description

Actalent in Lexington, MA is seeking a Clinical Development Lead to define short- and long-term objectives aligned with global clinical strategies. You will provide strategic leadership for phase 1-3 development programs and oversee global trials, protocol development, execution, and final reports.

This contract role is remote, supporting Eastern or Central Time, with approximately 25% travel. It offers long-term opportunity to own global late-phase programs from a clinical development