Director, Clinical Scientist (Respiratory)

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

• Take ownership of clinical execution and ensure accountability to high standards of quality and rigor
• Collaborate across functions with transparency and technical precision
• Foster an inclusive and high-performing team culture, offering mentorship and coaching where appropriate
• Communicate clearly and consistently, using data to inform decisions and recommendations
• Adapt readily to change and demonstrate resilience and curiosity in the face of ambiguity

Here's how you'll contribute:

• Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
• Act as a key scientific contributor to late-stage protocols and regulatory submissions
• Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader
• Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
• Interpret clinical data in collaboration with cross-functional colleagues and external partners
• Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans
• Participate in data review and medical monitoring activities
• Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
• Support development and execution of publication plans, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)

Leadership Responsibilities:

• Take ownership of clinical execution and ensure accountability to high standards of quality and rigor
• Collaborate across functions with transparency and technical precision
• Foster an inclusive and high-performing team culture, offering mentorship and coaching where appropriate
• Communicate clearly and consistently, using data to inform decisions and recommendations
• Adapt readily to change and demonstrate resilience and curiosity in the face of ambiguity

The Ideal Candidate will have:

• Advanced degree (PhD, PharmD, MD, MS, PMP ) and 9+ years of industry experience in clinical development, including 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

Education
PhD, PharmD, MD or equivalent is required; respiratory scientific background preferred

Nice to Have (Optional):

• Experience with both small molecule and biologic modalities
• Familiarity with AI/ML-driven drug discovery platforms
• Previous involvement in BLA or MAA submissions

Location: This role will be based out of our headquarters in Somerville, MA or secondary location, Andover, MA. 

Why Join Us
This is a unique opportunity to shape the future of respiratory medicine within a company pioneering Generative Biology™. At Generate:Biomedicines, you’ll be part of a fast-moving, purpose-driven team translating cutting-edge science into meaningful therapies for patients.

 

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Generate:Biomedicines is committed to equal employment opportu