Senior Director, Clinical Scientist (Respiratory)

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 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

Generate:Biomedicines is seeking a highly motivated and experienced Senior Director, Clinical Scientist to lead the clinical development of our respiratory programs, with a focus on asthma and COPD. This individual will own end-to-end clinical development strategy and execution —from early clinical studies through late-stage pivotal trials and regulatory submissions.  The Senior Director will serve as the clinical science lead on cross-functional study teams, drive protocol development, data analysis, and regulatory strategy, and ensure scientific and operational excellence across the respiratory portfolio. This role will have significant visibility and impact, partnering with senior leadership and regulatory authorities to shape the path of development for breakthrough respiratory medicines.

The role will report to the Vice President, Global Respiratory Products Leader.

Here's how you will contribute:

• Serve as the clinical science lead across the respiratory portfolio, providing scientific and strategic leadership for early- and late-stage studies (asthma and/or COPD).
• Drive development and execution of clinical development plans (CDPs), target product profiles (TPPs), and end-to-end risk–benefit assessments.
• Design and develop clinical trial protocols and associated documents in collaboration with clinical development and operations leaders.
• Lead development of study plans, data review plans, and the clinical components of regulatory submissions (IBs, CSRs, briefing books, BLAs, MAAs).
• Partner with Biostatistics, Data Management, and Safety colleagues to ensure scientific rigor and regulatory compliance.
• Interpret clinical data and provide strategic insights to support decision-making and lifecycle planning.
• Guide oversight of data monitoring committees (DSMB, Endpoint Adjudication Committee) for late-stage studies.
• Provide strategic input into publication strategy and ensure timely delivery of abstracts, manuscripts, and presentations.
• Act as a senior representative with external stakeholders, including investigators, KOLs, CROs, and regulators.
• Lead, mentor, and develop a team of clinical scientists, fostering a high-performance, inclusive culture.
• Leadership Responsibilities
• Set a high bar for clinical excellence and accountability across the team.
• Foster an inclusive, high-performing team culture with mentorship and career development opportunities.
• Promote transparent, data-driven communication to align teams on priorities and outcomes.
• Encourage adaptability, resilience, and innovation across the respiratory development programs.

The Ideal Candidate will have:

• Advanced degree (PhD, PharmD, MD, or equivalent) required.
• 12+ years of industry experience in clinical development, with significant end-to-end experience in respiratory (asthma and/or COPD) programs.
• Demonstrated success in both early- and late-stage clinical trials, including regulatory submissions (BLA, MAA).
• Deep knowledge of clinical research methodologies, GCP, and global regulatory requirements.
• Strong analytical, communication, and leadership skills with the ability to influence across functions and levels.
• Track record of successfully leading clinical strategy, execution, and regulatory engagement for pivotal trials.
  Nice to Have (Optional)
• Experience with both small molecule and biologic modalities.
• Familiarity with AI/ML-driven drug discovery platforms.
• Establi