United States onlyThe Role:
Generate:Biomedicines is seeking an experienced and strategic cross-functional team leader accountable for designing and delivering our late-stage respiratory programs, including asthma and COPD. Reporting directly to the Chief Medical Officer, this is a senior level business leader who will also build and develop a team of high functioning of physicians and scientists with accountability for the global clinical trials, collaborating with other key stakeholders to ensure rigorous safety oversight, data integrity, and strategic alignment. The ideal candidate is an MD with significant industry experience in respiratory medicine and a track record of driving executional excellence in pivotal trials.
Here's how you will contribute:
- Leads a high performing Respiratory Product Strategy Team (RPST) comprised of cross-functional leaders accountable for setting the strategy for the late stage respiratory programs
- Develops high quality, ambitious development plans for asthma and COPD programs, aligned with late-stage and corporate objectives and compliant with all relevant regulations
- Recruits, mentors and develops a team of late-stage clinicians and scientists
- Collaborates with Head of Safety and PV to define risk-benefit profiles
- Collaborates with Clinical operations and CRO to deliver study to timelines and budget
- Oversees protocol development and clinical/scientific content for regulatory submissions and interactions
- Provides medical leadership and awareness of evolving external landscape for late-stage clinical trials in respiratory diseases (asthma, COPD)
- Drives development and refinement of Target Product Profiles (TPPs), Target Product Claims, and clinical development strategies
- Oversee protocol development, study design, medical review of data, and safety monitoring
- Serve as the primary medical contact for clinical sites, investigators, and regulatory bodies
- Guide interactions with external stakeholders including KOLs, advisory boards, and CROs
- Represent Generate externally at scientific, medical, and regulatory meetings
Leadership Responsibilities
- Hold teams to high standards for technical and collaborative performance
- Build and develop a diverse, high-performing, and inclusive team culture
- Promote enterprise thinking and cross-functional alignment with strategic goals
- Communicate with clarity, courage, and empathy across all levels of the organization
- Foster resilience, adaptability, and informed risk-taking in pursuit of innovation
The Ideal Candidate will have:
- MD or PhD required; MD strongly preferred. Board certification in Pulmonology or Allergy and Immunology, or Rheumatology preferred.
- 10+ years of drug development experience in the biopharma industry
- Deep expertise in respiratory diseases (asthma, COPD) and late-stage clinical trials
- Recent BLA submission experience Demonstrated success in leading pivotal global studies and regulatory interactions
- Strong analytical, communication, and cross-functional leadership skills
- Proven ability to influence internal and external stakeholders, including investigators and health authorities
Nice to Have (Optional):
- Previous work in both large pharma and biotech settings
- Knowledge of global regulatory requirements (e.g., FDA, EMA)
Location: Somerville, MA / Andover, MA; remote (U.S.) optional with travel to HQ based on business needs.
Why Join Us
This is a unique opportunity to shape the future of respiratory medicine at a company pioneering Generative Biology™. You’ll be empowered to lead transformative trials in a collaborative, mission-driven environment, surrounded by relentless problem solvers who are reimagining what’s possible in drug discovery and development.
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.
Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
