Director, Clinical Scientist (Asthma and COPD)

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 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 

Education 
PhD, PharmD, MD or equivalent 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 

Who Will Love This Job:

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.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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