Senior Director, Medical Monitor – Respiratory Indications

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $277k - $400k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Provide day-to-day medical oversight for late-stage asthma and/or COPD clinical trials, ensuring patient safety, protocol compliance, data integrity, and inspection readiness • Serve as primary medical contact for clinical sites, investigators, and CROs • Perform subject eligibility review and ongoing data reviews • Manage study queries and identify and assess protocol deviations • Serve on Clinical Development, Safety Management, and Study Execution teams • Contribute to and review core clinical and regulatory documents, including IB, ICF, RFI, study protocols, and DSUR • Support study oversight committees, including DSMB and endpoint adjudication committees • Collaborate with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance • Interpret clinical trial data and contribute to study reports, regulatory filings, and publications • 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

🎯 Requirements

• MD (required) • 8+ years of clinical development experience in the biopharma industry • Extensive expertise in asthma and respiratory clinical trial design, oversight, and execution • Strong cross-functional leadership and communication skills • Proven ability to collaborate with internal teams and external stakeholders • Board certification in Pulmonology or Allergy & Immunology preferred • 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 • Additional scientific training (e.g., fellowship, MPH) a plus

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package