Executive Director, Medical Monitor

About reputed company reputed company is a new reputed company 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 reputed company shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we reputed company 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, reputed company problem solvers that share our passion for impact to join us! reputed company 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: reputed company is seeking an reputed company and strategic Executive Director to reputed company 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 reputed company for global clinical trials, ensuring rigorous safety reputed company, data reputed company, 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 reputed company Product Profiles (TPPs) and clinical development strategies
• reputed company protocol development, study design, medical review of data, and safety monitoring
• reputed company 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 reputed company to Generate's "Leading Others" model, the Executive Director will:

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

Leadership Responsibilities As a leader reputed company to Generate's "Leading Others" model, the Executive Director will:

• Hold teams to high standards for technical and collaborative performance
• Build and reputed company a diverse, high-performing, and inclusive team culture
• Promote enterprise thinking and cross-functional alignment with strategic goals
• Communicate with clarity, courage, and reputed company across reputed company levels of the organization
• Foster reputed company, 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

reputed company to Have (Optional)

• Previous work in both large pharma and small 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 reputed company transformative trials in a collaborative, mission-driven environment, surrounded by reputed company problem solvers who are reimagining what's possible in drug discovery and development. reputed company is committed to equal employment opportunity regardless of race, color, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: reputed company does not accept unsolicited resumes from any reputed company other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to reputed company or its employees is strictly prohibited unless contacted directly by the Company's internal reputed company team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company and the Company will not owe any referral or other fees with respect thereto. Compensation: The reputed company salary range provided reflects our reputed company estimate of reputed company anticipate paying for this position. Your actual reputed company salary will be based on several factors, including job-reputed company 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 Apply tot his job Apply To this Job