New · posted Nov 7
Generate Biomedicines · Biotechnology
Director, Clinical Scientist (Respiratory)
- Somerville, MA
- Hybrid
- Full-time
- Director
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)
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.
What you need
The Ideal Candidate will havenice to 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)nice to have
- Experience with both small molecule and biologic modalities
- Familiarity with AI/ML-driven drug discovery platforms
- Previous involvement in BLA or MAA submissions
What you'll do
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
Pay and benefits
$186,000 – $279,000 a year
Employer providedAnnual bonus
Equity compensation
Competitive benefits package
Where you'll work
Somerville, MAHybridOpen in Maps (opens in a new tab)
More jobs in Somerville, MAFrom the posting
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.
Per Year Salary Range
$186,000—$279,000 USD
Equal opportunity, accessibility and legal noticesGenerate Biomedicines's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts64 roles publishing pay
Director roles in the US219 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $186,000 | — | $279,000 |
| Massachusetts (middle half) | $254,500 | $298,500 | $320,875 |
| All US (middle half) | $255,250 | $299,500 | $333,000 |
This role: Generate Biomedicines's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 283 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Generate Biomedicines's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Clinical trial conduct11
- Documentation and SOPs4
- GMP and compliance3
- Lab testing and methods2
- Regulatory submissions2
- Data and digital systems2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
Company hiring pulse
Generate Biomedicines on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 3
- Locations
By discipline
- Clinical3 75%
- Quality1 25%
By level
- Director3 75%
- Manager1 25%
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Director, Clinical Scientist (Respiratory) at Generate Biomedicines
Open until filled. $186K–$279K a year, employer provided.