Vice President, Global Respiratory Products Leader

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 addition of a cover letter with a high level overview of your direct expertise in leading late stage clinical trials in asthma and/or COPD would be greatly appreciated ***

The 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 recruit and develop a team of physicians and scientists with accountability for the global clinical trials collaborating with PV 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.

Heres 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
• Direct management and development of medical monitors and clinical scientists
• 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 manages late-state 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 Claimsand 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 (required) board certification in Pulmonology or Allergy and Immunology Medicine preferred
• 10 years of clinical development experience in the biopharma industry
• Deep expertise in respiratory diseases (asthma COPD) and late-stage clinical trials
• 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

Education:

• MD required; additional scientific training (e.g. fellowship MPH) a plus

Nice to Have (Optional):

• Previous work in both large pharma and biotech settings
• Knowledge of global regulatory requirements (e.g. FDA EMA)
• Recent successful BLA submission preferred

Location: Somerville MA / Andover MA; remote (U.S.) optional withtravel 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. Youll be empowered to lead transformative trials in a collaborative mission-driven environment surrounded by relentless problem solvers who are reimagining whats possible in drug discovery and development.

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Generate:Biomedicines iscommitted 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.