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 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. . About Generate:Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.   Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion,