Executive Director of Strategic Clinical Development

Regulatory Jobs; Lexington (MA); On-site; USD 315,000 - 370,000; Full time

Job summary

Kiniksa Pharmaceuticals, a commercial-stage biopharma focused on cardiovascular diseases, seeks a Clinical Development Lead to oversee clinical programs. Based in Lexington, MA, this on-site role provides medical leadership from early development through regulatory approval.

The ideal candidate holds MD/PhD/PharmD with 8–12+ years in biotech/pharma, demonstrates cross-functional leadership, trial design expertise, regulatory interaction experience, and exceptional communication.

Qualifications

• Deep clinical experience in trial design and interpretation.
• Leadership across cross-functional teams and programs.
• Experience interacting with regulatory authorities and submitting IND/CTAs.
• Strong communication and presentation skills.
• Ability to translate strategy into actionable development plans.

Responsibilities

• Serve as clinical lead on cross-functional development teams and shape the overall clinical development strategy.
• Lead trial design and strategies, including study protocols, IBs, and CSRs.
• Collaborate with Clinical Operations to execute trials, recruitment, and data management.
• Coordinate with Biostatistics, Regulatory, Medical Affairs, and Pharmacovigilance to ensure quality execution.
• Support regulatory submissions and engage with health authorities and thought leaders.
• Provideclinical insights to support business development and due diligence.

Skills

Cross-functional leadership

Clinical trial design

Regulatory interactions

Communication skills

Strategic thinking

Education

MD, PhD, or PharmD

Job description

Kiniksa Pharmaceuticals, a commercial-stage biopharma focused on cardiovascular diseases, seeks a Clinical Development Lead to oversee clinical programs. Based in Lexington, MA, this on-site role provides medical leadership from early development through regulatory approval.

The ideal candidate holds MD/PhD/PharmD with 8–12+ years in biotech/pharma, demonstrates cross-functional leadership, trial design expertise, regulatory interaction experience, and exceptional communication.