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 millionin funding providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover Massachusetts with 300 employees.

The Role:

Generate:Biomedicinesisseekinga 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 deepexpertise in late-stage clinical trial design and execution in respiratory indications along with a proactive solution-oriented mindset.

Heres 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)

LeadershipResponsibilitie

• Take ownership of clinical execution and ensure accountability tohigh standardsof 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 anddemonstrateresilience and curiosity in the face of ambiguity

The Ideal Candidate will have:

• Advanced degree (PhD PharmD MD MSPMP )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
• Previousinvolvement 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. AtGenerate:Biomedicinesyoullbe part of a fast-moving purpose-driven team translatingcutting-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 Companys 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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