Director, Clinical Scientist – Respiratory

🔥 2 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $186k - $279k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ 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

• Serve as clinical science lead and core member of clinical development teams for respiratory studies • Support day-to-day study execution in alignment with protocols, timelines, and regulatory requirements • Design and develop clinical trial protocols and associated documents • Drive development of clinical components of regulatory documents • Participate in medical monitoring and review clinical data for quality, safety, and protocol compliance • Participate in site selection, initiation, and ongoing engagement • Provide scientific support to investigators and address protocol-related inquiries • Track study progress, identify risks, and implement mitigation strategies • Serve as a key scientific contact for CROs and vendors • Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams • Contribute to governance meetings, study updates, data summaries, and risk assessments • Ensure inspection readiness and support audit/inspection activities • Support publication plans, abstracts, and manuscripts • Contribute to target product profiles, clinical development plans, and risk-benefit assessments • Support oversight committees for late-stage asthma studies • Foster an inclusive, high-performing team culture through mentorship and coaching

🎯 Requirements

• Advanced degree (PhD, PharmD, MD, MS, PMP) • 9+ years of industry experience in clinical development • Direct experience in late-stage respiratory (asthma and/or COPD) studies • Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP • Demonstrated ability to lead clinical science strategy and execution in late-stage trials • Excellent analytical, communication, and cross-functional collaboration skills • Prior experience authoring clinical protocols, CSRs, and regulatory documents

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package • Remote work option in the U.S. with travel to headquarters based on business needs

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