Executive Director, Medical Monitor

at Generate:Biomedicines
💰 $281k-$422k
🇺🇸 United States - Remote
⚖️ Finance & Legal Executive

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 Role:

Generate:Biomedicines is seeking an experienced and strategic Executive Director to lead medical monitoring and clinical development activities for our late-stage respiratory programs, including asthma and COPD. This role will report directly to the Chief Medical Officer and serve as the medical lead for global clinical trials, ensuring rigorous safety oversight, data integrity, and strategic alignment. The ideal candidate is an MD with significant industry experience in respiratory medicine and a track record of driving executional excellence in pivotal trials.

Here’s how you will contribute:

  • Provide medical leadership and monitoring for late-stage clinical trials in respiratory diseases (asthma, COPD)
  • Drive development and refinement of Target Product Profiles (TPPs) and clinical development strategies
  • Oversee protocol development, study design, medical review of data, and safety monitoring
  • Lead cross-functional interactions with Clinical Operations, Regulatory Affairs, Biostatistics, and Pharmacovigilance
  • Serve as the primary medical contact for clinical sites, investigators, and regulatory bodies
  • Interpret clinical trial data and contribute to study reports, publications, and regulatory filings
  • Guide interactions with external stakeholders including KOLs, advisory boards, and CROs
  • Represent Generate externally at scientific, medical, and regulatory meetings

Leadership Responsibilities

As a leader aligned to Generate’s “Leading Others” model, the Executive Director will:

  • Hold teams to high standards for technical and collaborative performance
  • Build and develop a diverse, high-performing, and inclusive team culture
  • Promote enterprise thinking and cross-functional alignment with strategic goals
  • Communicate with clarity, courage, and empathy across all levels of the organization
  • Foster resilience, adaptability, and informed risk-taking in pursuit of innovation

Leadership Responsibilities

As a leader aligned to Generate’s “Leading Others” model, the Executive Director will:

  • Hold teams to high standards for technical and collaborative performance
  • Build and develop a diverse, high-performing, and inclusive team culture
  • Promote enterprise thinking and cross-functional alignment with strategic goals
  • Communicate with clarity, courage, and empathy across all levels of the organization
  • Foster resilience, adaptability, and informed risk-taking in pursuit of innovation

The Ideal Candidate will have:

  • MD (required), board certification in Pulmonology or Internal Medicine preferred
  • 10+ years of clinical development experience in the biopharma industry
  • Deep expertise in respiratory diseases (asthma, COPD) and late-stage clinical trials
  • Demonstrated success in leading pivotal global studies and regulatory interactions
  • Strong analytical, communication, and cross-functional leadership skills
  • Proven ability to influence internal and external stakeholders, including investigators and health authorities

Education

  • MD required; additional scientific training (e.g., fellowship, MPH) a plus

Nice to Have (Optional)

  • Previous work in both large pharma and biotech settings
  • Knowledge of global regulatory requirements (e.g., FDA, EMA)
  • Recent successful BLA submission preferred

Why Join Us

This is a unique opportunity to shape the future of respiratory medicine at a company pioneering Generative Biology™. You’ll be empowered to lead transformative trials in a collaborative, mission-driven environment, surrounded by relentless problem solvers who are reimagining what’s possible in drug discovery and development.

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.

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

$281,000—$422,000 USD

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