Director, Clinical Scientist (Respiratory)

Generate Biomedicines; Somerville (MA); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Equity compensation

Annual bonus

Job summary

Generate Biomedicines in Somerville, MA is seeking a Director, Clinical Scientist to lead the clinical science strategy for asthma and COPD programs through Phase 2/3. You will drive protocol development, data analysis, and regulatory submissions.

Reporting to Senior Director, you will partner with Clinical Operations, Regulatory, Biostatistics, and Safety to ensure data quality, participant safety, and timely study delivery; a strong publication mindset is expected.

Qualifications

• Advanced degree and 9+ years in clinical development, including late-stage respiratory studies.
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP.
• Ability to lead clinical science strategy and execution in late-stage trials.
• Excellent analytical, communication, and cross-functional collaboration skills.
• Experience authoring clinical protocols, CSRs, and regulatory documents.

Responsibilities

• Lead clinical science for respiratory studies (asthma and COPD) on Phase 2/3 trials.
• Develop protocols, CSRs, and regulatory documents with cross-functional teams.
• Monitor data quality and safety; escalate issues with partners.
• Support site selection, initiation, and investigator interactions.
• Track study progress, identify risks to timelines or data integrity; propose mitigations.
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams.
• Contribute to governance meetings with data summaries and risk reviews.
• Support publication plans and medical communications.
• Contribute to TPPS and risk-benefit assessments.
• Assist oversight committees (DSMB, Endpoint Adjudication) during late-stage asthma studies.

Skills

Clinical development leadership

Late-stage respiratory expertise

Regulatory knowledge & GCP

Cross-functional collaboration

Scientific writing ability

Education

PhD/MD/PharmD or equivalent

Job description

The Role:

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.

Here's how you will contribute:

• 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)

Leadership Responsibilities:

• 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

The Ideal Candidate will have:

• 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 Have (Optional):

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

Location:

Somerville, MA / Andover, MA; remote (U.S.) optional with travel to HQ based on business needs.

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.

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.

Per Year Salary Range

$186,000—$279,000 USD