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Open nowPosted 7 hours ago

Director, Clinical Scientist (Respiratory)

Generate Biomedicines24 open roles

Pay
$186,000 – $279,000 a year
Where
US
Work mode
Remote
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Your applicationOpen nowDirector, Clinical Scientist (Respiratory)Generate Biomedicines · US

  1. YouYes, apply to this one.

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The clock on this job

Early applications get read.

13.7% of postings close within 7 days. Measured by our own scanner across the market. Generate Biomedicines postings stay open a median of 24 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.8%3 days
  3. 13.7%7 days
  4. 22.1%14 days
  5. 37.6%30 days
  6. 59.1%60 days
This job: posted 7 hours ago

Generate Biomedicines median: 24 days open

The posting

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Clinical Scientist (Respiratory) based in the United States.

As Director, Clinical Scientist (Respiratory), you will play a key role in advancing clinical development programs focused on respiratory diseases, particularly asthma and COPD. You will serve as the clinical science lead for Phase 2 and Phase 3 studies, driving scientific strategy, trial design, and clinical execution. Working closely with multidisciplinary teams, you will oversee protocol development, clinical data interpretation, and regulatory documentation. Your expertise will help ensure the quality, integrity, and scientific rigor of late-stage clinical trials while supporting patient safety and regulatory compliance. You will collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to deliver successful study outcomes. You will also contribute to clinical development strategies, risk-benefit assessments, and scientific publications. This is an opportunity to influence the development of innovative medicines within a collaborative, research-driven biotechnology environment.

Accountabilities

  • Serve as the clinical science lead and a core member of clinical development teams overseeing one or more respiratory studies in asthma and/or COPD.
  • Support day-to-day clinical study execution, ensuring compliance with protocols, timelines, quality standards, and regulatory requirements.
  • Lead and contribute to the development of late-stage clinical trial protocols and associated documentation, including clinical study plans, data review plans, case report forms (CRFs), database designs, and statistical analysis plans.
  • Drive the preparation of clinical sections of regulatory documents, including Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and regulatory briefing materials.
  • Participate in medical monitoring activities by reviewing and interpreting ongoing clinical data to ensure data quality, participant safety, and protocol compliance.
  • Identify and escalate clinical or operational issues in collaboration with internal teams and external partners.
  • Contribute to site selection, study initiation, and ongoing site engagement, providing scientific guidance to investigators and addressing protocol-related questions.
  • Support clinical operations teams in study delivery, monitoring progress against milestones, identifying risks, and implementing mitigation strategies.
  • Act as a key scientific point of contact for Contract Research Organizations (CROs) and external vendors.
  • Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to ensure coordinated trial execution.
  • Prepare and present study updates, clinical data summaries, and key risks or issues during internal governance meetings.
  • Maintain inspection readiness through high-quality documentation and support audit and regulatory inspection activities.
  • Contribute to publication strategies, abstracts, scientific manuscripts, and other clinical communication materials.
  • Support the development of Target Product Profiles (TPPs), clinical development plans, and risk-benefit assessments.
  • Assist medical monitors with the management and oversight of committees for late-stage asthma studies, including Data and Safety Monitoring Boards (DSMBs) and Endpoint Adjudication Committees.
  • Promote scientific rigor, accountability, transparency, and cross-functional collaboration while mentoring and supporting colleagues where appropriate.
  • Communicate recommendations clearly, using clinical evidence and data to guide decisions, while adapting effectively to evolving priorities and complex challenges.
  • An advanced degree such as a PhD, PharmD, MD, MS, or PMP certification.
  • At least 9 years of industry experience in clinical development.
  • Direct experience supporting or leading late-stage clinical trials in respiratory indications, particularly asthma and/or COPD.
  • Strong knowledge of clinical research methodologies, clinical trial design, regulatory guidelines, and Good Clinical Practice (GCP).
  • Demonstrated ability to lead clinical science strategy and execution across Phase 2 and Phase 3 studies.
  • Proven experience authoring clinical trial protocols, Clinical Study Reports (CSRs), and regulatory documentation.
  • Strong analytical skills and the ability to interpret complex clinical data and translate findings into actionable recommendations.
  • Excellent written and verbal communication skills, including experience presenting scientific information to internal and external stakeholders.
  • Strong cross-functional collaboration skills and the ability to work effectively with multidisciplinary teams and external partners.
  • A proactive, solution-oriented mindset, with strong organizational skills and the ability to manage competing priorities.
  • Demonstrated leadership capabilities, including accountability, mentorship, and the ability to foster an inclusive and high-performing team environment.
  • Adaptability, resilience, and curiosity when navigating ambiguity and changing clinical development priorities.
  • Experience working with both small-molecule drugs and biologic therapies.
  • Familiarity with artificial intelligence and machine learning-driven drug discovery platforms.
  • Previous involvement in Biologics License Application (BLA) or Marketing Authorization Application (MAA) submissions.
  • Annual base salary range of $186,000–$279,000.
  • Eligibility for an annual performance-based bonus.
  • Equity compensation.
  • Competitive employee benefits package.
  • Remote work option for US-based candidates, with travel to headquarters as required by business needs.
  • Opportunity to contribute to innovative clinical-stage drug development programs.
  • Collaborative, multidisciplinary working environment.
  • Opportunities to contribute to scientific innovation and the development of next-generation medicines.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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