Senior Director, Clinical Scientist (Respiratory)

• 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.
• Established network with respiratory KOLs and regulatory experts

Who Will Love This Job:

This is a unique opportunity to lead end-to-end clinical development of respiratory programs in a company pioneering Generative Biology™. At Generate:Biomedicines, you will shape strategy, drive pivotal trials, and help bring transformative therapies to patients with respiratory disease.

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.

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