Director, Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Report to the Senior Vice President of Clinical Development.

• Deliver medical oversight, scientific leadership, and clinical expertise in IPF/ILD throughout the clinical trial lifecycle.

• Drive the strategy and development of clinical trial protocols, including endpoints, inclusion/exclusion criteria, and overall trial design.

• Establish medical monitoring, safety, and risk mitigation strategies in collaboration with the Medical Monitor.

• Contribute to the assumptions of the statistical analysis plan and the clinical significance of the statistical design.

• Assist in identifying and selecting sites based on expertise in the disease area.

• Provide medical insights for trial amendments and engage in study-specific regulatory interactions.

• Act as a disease-state expert, offering medical guidance to the Medical Monitor and clinical trial team.

• Review Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), safety signals, eligibility deviations, protocol exceptions, and violations.

• Support the preparation of materials for the Data Safety Monitoring Board (DSMB) and Safety Review Committee.

• Ensure that trial conduct complies with Good Clinical Practice (GCP) and prioritizes patient safety.

• Facilitate cross-functional collaboration with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external Contract Research Organizations (CROs).

• Provide medical guidance to site investigators and address clinical or disease-related inquiries.

• Conduct site visits as necessary.

• Co-lead blinded data review meetings and assess emerging safety and efficacy data.

• Oversee the medical interpretation of safety and efficacy outcomes for Clinical Trial Reports and assist in interim analyses and futility assessments.

• Lead the development and writing of the Clinical Study Report.

• Engage in interactions with regulatory agencies and co-lead End-of-Phase 2 (EOP2) materials with Regulatory Affairs.

• Address inquiries from health authorities.

• Present clinical data at advisory boards and investigator meetings while supporting publications and conference presentations.

⛳️ Requirements

• An advanced clinical or scientific degree (e.g., APRN, RRT, PhD, PharmD) with 5–7+ years of experience in IPF/ILD clinical care, research, or drug development.

• At least 3–5+ years of clinical development experience, with proven involvement in the design and execution of Phase 2–3 clinical trials, preferably on a global scale.

• Required therapeutic expertise in IPF, ILD, or a closely related respiratory disease area.

• Demonstrated proficiency in clinical trial protocol development, including endpoints, eligibility criteria, safety monitoring, and risk mitigation strategies.

• Strong clinical judgement and dedication to patient safety, with experience in evaluating safety signals, protocol deviations, and benefit-risk assessments.

• Experience in reviewing and interpreting clinical safety and efficacy data, translating findings into actionable clinical and development decisions.

• Working knowledge of ICH-GCP, clinical research standards, and global regulatory requirements, with experience facilitating interactions with health authorities.

• Proven capability to lead and influence cross-functional teams and collaborate effectively with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external partners.

• Exceptional written and verbal communication skills, with the ability to engage effectively with investigators, clinical sites, CROs, regulatory agencies, and internal stakeholders.

• Strong strategic thinking and business acumen, with the ability to align trial-level decisions with broader clinical development and program objectives.

• Capacity to work effectively in a dynamic, collaborative environment while balancing strategic responsibilities with hands-on involvement in clinical trial execution.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.