Director, Clinical Scientist – Respiratory Indications

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

📋 Description

• Act as the clinical science lead and integral member of clinical development teams focused on respiratory studies.

• Assist in the daily execution of studies while ensuring alignment with protocols, timelines, and regulatory standards.

• Create and develop clinical trial protocols along with related documentation.

• Prepare clinical components of regulatory submissions.

• Evaluate and interpret clinical data to guarantee data integrity, participant safety, and adherence to protocols.

• Engage in site selection, initiation, and continuous involvement.

• Monitor study progress, recognize risks, and implement strategies for mitigation.

• Act as the scientific liaison for CROs and vendors.

• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Safety teams.

• Participate in governance meetings, provide study updates, summarize data, and conduct risk assessments.

• Ensure inspection readiness and assist with audits and inspections.

• Support the development of publications, abstracts, and manuscripts.

• Contribute to Target Product Profiles (TPPs), clinical development plans, and risk-benefit evaluations.

• Provide oversight for committees concerning late-stage asthma studies.

• Mentor and coach team members when appropriate.

⛳️ Requirements

• Advanced degree (PhD, PharmD, MD, MS, PMP).

• Over 9 years of industry experience in clinical development.

• Direct experience in late-stage respiratory studies (asthma and/or COPD).

• Strong understanding of clinical research methodologies, regulatory guidelines, and Good Clinical Practice (GCP).

• Proven ability to lead clinical science strategies and execution in late-stage trials.

• Exceptional analytical, communication, and cross-functional collaboration skills.

• Previous experience in authoring clinical protocols, Clinical Study Reports (CSRs), and regulatory documents.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.

• Remote work option available in the U.S. with travel to headquarters based on business requirements.