Director, Clinical Scientist (Respiratory Indications)

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 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 required; respiratory scientific background preferr