Director, Clinical Scientist (Asthma and COPD)

Generate Biomedicines•Somerville, MA

9d•$186,000 - $279,000

About The Position

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 million in 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 a highly motivated and experienced Director, Clinical Scientist to support the development of our respiratory programs, with a focus on asthma and COPD. This individual will serve as the clinical science lead on cross-functional study teams for Phase 2 and 3 trials, driving protocol development, data analysis, and regulatory documentation. The ideal candidate will bring deep expertise in late-stage clinical trial design and execution in respiratory indications, along with a proactive, solution-oriented mindset. Here's how you will 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 Responsibilitie 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

Requirements

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

Nice To Haves

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

Responsibilities

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)
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