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Director, Clinical Scientist – Respiratory Indications
Generate BiomedicinesClinical-stage AI drug discovery company seeking a clinical science leader for late-stage asthma and COPD trials. Driving protocols, data analysis, regulatory submissions, and cross-functional execution.
Posted 8/21/2026full-timeSomerville • Massachusetts • 🇺🇸 United StatesLead💰 $186,000 - $270,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development for late-stage respiratory studies, including protocol design, regulatory document preparation, and data analysis. Proven ability to lead cross-functional teams and ensure compliance with regulatory standards while fostering a collaborative team environment.
Highest-signal resume keywords
Clinical Development LeadershipProtocol Design and DevelopmentRegulatory Document PreparationData Analysis and InterpretationCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Research MethodologiesRegulatory GuidelinesGood Clinical Practice (GCP)Clinical Protocol AuthoringStatistical Analysis PlansData Review PlansClinical Study PlansDatabase DesignRisk-Benefit AssessmentTrial Execution Oversight
Soft Skills
Analytical SkillsCommunication SkillsMentorshipCoachingTeam Culture Development
Tools & Technologies
AI/ML-Driven Drug Discovery Platforms
Certifications & Qualifications
PhDPharmDMDMSPMP
Industry Keywords
Respiratory StudiesAsthmaCOPDBLA SubmissionsMAA SubmissionsClinical Trial ProtocolsClinical Study Reports (CSRs)Data ManagementMedical MonitoringOversight Committees
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Serve as clinical science lead and core member of clinical development teams for respiratory studies focused on asthma and/or COPD
- Support day-to-day study execution in alignment with protocols, timelines, and regulatory requirements
- Design and develop late-stage clinical trial protocols and associated documents, including clinical study plans, data review plans, CRFs, database designs, and statistical analysis plans
- Drive development of clinical components of regulatory documents, including IBs, CSRs, and briefing books
- Participate in medical monitoring by reviewing and interpreting clinical data to ensure data quality, participant safety, and protocol compliance
- Participate in site selection, initiation, and ongoing engagement; provide scientific support to investigators
- Contribute to trial execution and oversight by tracking milestones, identifying risks, proposing mitigation strategies, and serving as a scientific contact for CROs and vendors
- Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams
- Contribute to internal governance meetings through study updates, data summaries, and risk/issue presentations
- Ensure inspection readiness and support audit/inspection activities
- Support publication plans, abstracts, and manuscripts
- Contribute to TPPs, clinical development plans, and risk-benefit assessments
- Support management of oversight committees for late-stage asthma studies, such as DSMBs and Endpoint Adjudication Committees
- Take ownership of clinical execution and accountability for quality and rigor
- Foster an inclusive, high-performing team culture through mentorship and coaching
- Communicate data-informed decisions and recommendations
Requirements
What you’ll need- Advanced degree (PhD, PharmD, MD, MS, PMP) and 9+ years of industry experience in clinical development, including direct experience in late-stage respiratory (asthma and/or COPD) studies
- Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP
- Demonstrated ability to lead clinical science strategy and execution in late-stage trials
- Excellent analytical, communication, and cross-functional collaboration skills
- Prior experience authoring clinical protocols, CSRs, and regulatory documents
- Experience with both small molecule and biologic modalities (optional)
- Familiarity with AI/ML-driven drug discovery platforms (optional)
- Previous involvement in BLA or MAA submissions (optional)
Benefits
Comp & perks- Annual bonus
- Equity compensation
- Competitive benefits package
- Equal employment opportunity