Generate Biomedicines Visa Sponsorship USA

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, 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.