Job Description
About Generate:Biomedicines
Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.
We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!
Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.
\*\*\* The addition of a cover letter with a high-level overview of your direct expertise in leading late-stage clinical trials in asthma and/or COPD would be greatly appreciated ***
The Role:
Generate:Biomedicinesisseeking a strategic and experienced Senior Director to lead clinical development and medical monitoring for our late-stage asthma and COPD programs. This individual will report to the Vice Presidentof Clinical Development and serve as the medical lead for global asthma trials, ensuring scientific rigor, patient safety, and executional excellence. The ideal candidate is an MD with deep respiratory expertise and a passion for transforming asthma and COPDcare through innovative biologics.
Here’s how you will contribute:
Medical Lead for the Clinical Development Team (CDT) to deliver Phase 3 asthma and COPD studies
Provide medical leadership and oversight for late-stage clinical trials in asthma and COPD
Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthma and COPD
Serve as key author of late-stage clinical protocols, aligned with regulatory requirements
Author clinical and scientific content for regulatory submissions (e.g., BLA, MAA)
Oversee study design, protocol development, data review, and safety monitoring
Perform medical monitoring for late-stage studies, ensuring patient safety, protocol compliance, and data integrity
Serve as a member of the Safety Management Team (SMT)
Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
Serve as primary medical contact for clinical sites, investigators, and CROs
Interpret clinical trial data and contribute to study reports, regulatory filings, and publications
Represent Generate at internal and external scientific and medical meetings
Engage with external experts, advisory boards, and health authorities to support program goals
Leadership Responsibilities
Hold teams to high standards for technical and collaborative performance
Foster a high-performing, diverse, and inclusive team culture
Promote enterprise thinking and strategic alignment across functions
Communicate with clarity, courage, and empathy
Model resilience, adaptability, and informed risk-taking
The Ideal Candidate will have:
MD (required); board certification in Pulmonology or Allergy & Immunology preferred
8+ years of clinical development experience in the biopharma industry
Extensive expertise in asthma and respiratory clinical trial design
Experience leading late-stage trials and engaging with regulatory bodies
Strong cross-functional leadership and communication skills
Proven ability to collaborate with internal teams and external stakeholders
Education
MD required; additional scientific training (e.g., fellowship, MPH) a plus
Nice to Have (Optional)
- Experience in both large pharma and biotech settings
- Familiarity with global regulatory frameworks (e.g., FDA, EMA)
- Prior involvement in successful BLA or MAA submissions
Who Will Love This Job:
This is an exciting opportunity to shape the future of asthma care by advancing novel biologics using the power of generative biology. At Generate:Biomedicines, you’ll join a mission-driven team committed to scientific excellence!
Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies : Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.
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Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Per Year Salary Range
$277,000—$416,000 USD
