Senior Director, Clinical Development

TL;DR

Senior Director, Clinical Development (Respiratory): Execute global clinical development plans for a monoclonal antibody targeting SCF with an accent on preparing clinical documents, providing medical oversight for investigational sites, conducting research, and delivering medical/scientific leadership to study teams. Focus on strategic aspects of ILD and asthma programs, protocol design, regulatory submissions, safety data management, and collaboration with CROs and external experts.

Location: Fully remote from anywhere. Occasional domestic/international travel (5%–15%) expected.

Salary: $273,000–$372,000 Annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Provide medical/scientific input and advice to Clinical Scientists and Operations on study design, execution, and issue resolution.
• Collaborate with teams and CROs to prepare and finalize clinical study protocols, amendments, and Special Protocol Assessment agreements.
• Offer program-level medical oversight for regulatory documents including INDs, DSURs, Investigator Brochures, and NDA/CTD sections.
• Review interim/blinded data, manage safety tables/listings/narratives, evaluate mortality cases and SUSARs, and query PIs.
• Stay current on scientific/medical progress, build relationships with external experts, and represent the company externally.
• Contribute to strategic development of early and late-stage clinical programs.

Requirements

• MD; board certified/eligible, specialization in Pulmonary/Immunology a plus.
• Minimum 6+ years of clinical development experience in pharmaceutical/biotech industry.
• Previous experience conducting clinical trials in Respiratory a plus.
• Working knowledge of Good Clinical Practices, clinical methodology, protocol design, project management, and regulatory requirements.
• Global perspective and ability to work with diverse cultures/backgrounds/geographies.
• Excellent verbal and written communication skills.

Nice to have

• Experience in Respiratory clinical trials.
• Board certification/eligibility in Pulmonary/Immunology.

Culture & Benefits

• Comprehensive medical, dental, vision coverage, mental health support, wellbeing reimbursement, and Employee Assistance Program.
• Generous PTO, fertility/family-forming benefits, caregiver support, flexible schedules.
• 401(k) with company match, equity awards, Employee Stock Purchase Plan, company-paid life/disability insurance.
• Company Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship.
• Employee resource groups, service/recognition programs, volunteering opportunities.