Remote Global Clinical Development Lead

Actalent; United States; Remote; USD 179,000 - 207,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Paid Time Off

Job summary

Actalent is seeking a Clinical Development Lead to drive global clinical strategies for late-stage programs. The role involves leadership of phase 1-3 development, overseeing international trials and trial teams, and authoring final study reports.

You will guide protocol development, safety mitigation, and cross-functional collaboration to advance therapeutic targets. The position is remote and offers exposure to global late-phase programs from a clinical development perspective, with frequent

Qualifications

• 7+ years in clinical research, preferably in rare diseases.
• Regulatory experience including IND and/or NDA submissions.
• Excellent written and oral English communication.

Responsibilities

• Develop and define objectives aligned with global clinical strategies, communicating with clinical staff.
• Provide strategic leadership to phase 1-3 development programs and oversee global trials and teams.
• Lead protocol development, oversee study execution, and prepare final study reports.
• Identify and address safety issues within programs and develop mitigation strategies.
• Participate in Clinical Team and Operations meetings, discussing budgets and resources.
• Evaluate emerging data to inform therapeutic area strategies and design clinical plans.
• Collaborate with cross-functional teams to explore new targets and opportunities.
• Present at academic congresses, investigator meetings, and advisory meetings.
• Contribute to regulatory submissions by authoring clinical sections of dossiers.
• Conduct due diligence by evaluating external partners' clinical strategies.

Skills

Clinical research

Regulatory submissions

English communication

Job description

Actalent is seeking a Clinical Development Lead to drive global clinical strategies for late-stage programs. The role involves leadership of phase 1-3 development, overseeing international trials and trial teams, and authoring final study reports.

You will guide protocol development, safety mitigation, and cross-functional collaboration to advance therapeutic targets. The position is remote and offers exposure to global late-phase programs from a clinical development perspective, with frequent