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Generate:BiomedicinesDirector, Clinical Scientist (Respiratory)
Generate:Biomedicines is hiring a Director, Clinical Scientist specializing in respiratory programs to focus on asthma and chronic obstructive pulmonary disease. The employer is a clinical-stage generative…
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About This Role
Generate:Biomedicines is hiring a Director, Clinical Scientist specializing in respiratory programs to focus on asthma and chronic obstructive pulmonary disease. The employer is a clinical-stage generative biology company founded in 2018 that combines machine learning with large-scale experimentation to create protein-based medicines. This position can be performed remotely within the United States, with occasional business-related travel required to company headquarters in Somerville or Andover, Massachusetts, reporting to the Senior Director…
Job Description
Generate:Biomedicines is hiring a Director, Clinical Scientist specializing in respiratory programs to focus on asthma and chronic obstructive pulmonary disease. The employer is a clinical-stage generative biology company founded in 2018 that combines machine learning with large-scale experimentation to create protein-based medicines. This position can be performed remotely within the United States, with occasional business-related travel required to company headquarters in Somerville or Andover, Massachusetts, reporting to the Senior Director of Clinical Development.
This individual acts as the clinical science lead for Phase 2 and 3 trials, managing protocol creation, regulatory documentation, and data evaluation. The role suits a seasoned professional who can collaborate with cross-functional groups like biostatistics, safety, and regulatory affairs while supporting medical monitoring and trial execution. Ideal applicants bring deep expertise in late-stage respiratory clinical trials and a proactive attitude toward resolving operational risks.
Responsibilities
- Serve as the clinical science lead and core development team member for respiratory studies targeting asthma and COPD
- Manage daily trial activities to guarantee adherence to timelines, protocols, and regulatory requirements
- Design and author clinical protocols, study plans, case report forms, database designs, and statistical analysis plans
- Contribute to regulatory documents such as investigator brochures, clinical study reports, and briefing books
- Participate in medical monitoring by reviewing safety and efficacy data with external partners and cross-functional colleagues
- Assist with clinical site selection, startup, and ongoing investigator support
- Collaborate with clinical operations on trial oversight, milestone tracking, risk mitigation, and vendor coordination
- Take part in internal governance meetings by presenting study updates and discussing data summaries
- Maintain high documentation standards to support audit activities and inspection readiness
- Contribute to abstracts, manuscripts, target product profiles, and clinical development plans
- Support the medical monitor in overseeing late-stage committees including data safety monitoring boards and adjudication panels
Requirements
- Advanced degree such as a PhD, PharmD, MD, MS, or PMP
- Minimum of 9 years of industry experience in clinical development
- Direct background in executing late-stage respiratory studies focusing on asthma or COPD
- Solid understanding of clinical research methodologies, regulatory guidelines, and good clinical practice standards
- Proven ability to direct clinical science strategy for late-stage clinical trials
- Demonstrated background in authoring clinical protocols, study reports, and regulatory filings
Qualifications
- Prior involvement with both small molecule and biologic drug modalities
- Familiarity using artificial intelligence or machine learning platforms for drug discovery
- Previous participation in biologic license applications or marketing authorization applications
Core Skills
Benefits
- Annual bonus eligibility
- Equity compensation
- Competitive benefits package
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the location policy for this role?
This position can be performed remotely from the United States, though travel to company headquarters in Somerville or Andover, Massachusetts, is required based on business needs.
What is the salary range for the Director, Clinical Scientist position?
The annual base salary ranges from USD 186,000 to 279,000, determined by factors such as relevant skills, background, education, and market dynamics.
What experience level is required to apply?
Candidates must hold an advanced degree like a PhD, PharmD, MD, MS, or PMP, alongside at least 9 years of industry experience in clinical development that includes late-stage respiratory studies.
What additional compensation is offered beyond base pay?
Employees in this role are eligible for an annual bonus, equity compensation, and a competitive benefits package.
Sample Interview Questions
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