Director, Clinical Scientist

Generate Biomedicines•Somerville, MA

6d•Remote

About The Position

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. The role will report to the Senior Director, Clinical Development.

Requirements

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

Nice To Haves

Experience with both small molecule and biologic modalities
Familiarity with AI/ML-driven drug discovery platforms
Previous involvement in BLA or MAA submissions

Responsibilities

Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
Act as a key scientific contributor to late-stage protocols and regulatory submissions; Design and develop clinical trial protocols and associated documents (e.g. clinical study plans, data review plans, case report forms (CRFs), database design, statistical analysis plans) in collaboration with the clinical development leader and Drive development of clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
Participate in medical monitoring activities: review and interpret clinical data on an ongoing basis in collaboration with cross-functional colleagues and external partners to ensure data quality, participant safety, and protocol compliance. Escalate issues as appropriate.
Participate in site selection, initiation, and ongoing engagement; provide scientific support to investigators and address protocol-related inquiries
Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight: track study progress against milestones and identify risks to timelines or data integrity, propose and help implement mitigation strategies, and serve as key scientific contact for CROs and vendors.
Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
Contribute to internal governance meetings (presenting or preparing study updates, data summaries, and key risks/issues)
Ensure inspection readiness (maintain high-quality documentation and support audit/inspection activities).
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)
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