No longer accepting applications (expired, filled, etc.)
Generate:Biomedicines
Director, Clinical Scientist (Respiratory Indications)
The Director, Clinical Scientist will lead clinical science efforts for respiratory programs focused on asthma and COPD, driving late-stage clinical trial design, protocol development, data analysis, and regulatory documentation. This role involves collaboration across cross-functional teams to ensure successful trial execution and contribute to scientific and regulatory strategies.
Key Responsibilities
- • Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
- • Act as a key scientific contributor to late-stage protocols and regulatory submissions
- • Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader
- • Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
- • Interpret clinical data in collaboration with cross-functional colleagues and external partners
- • Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans
- • Participate in data review and medical monitoring activities
- • Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight
- • Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
- • 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
Required
- • 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
- • PhD, PharmD, MD or equivalent required
Preferred
- • Respiratory scientific background preferred
- • Experience with both small molecule and biologic modalities
- • Familiarity with AI/ML-driven drug discovery platforms
- • Previous involvement in BLA or MAA submissions
Benefits & Perks
- • Annual bonus
- • Equity compensation
- • Competitive benefits package
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.
Here's how you will contribute:
PhD, PharmD, MD or equivalent required; respiratory scientific background preferred
Nice to Have (Optional)
This is a unique opportunity to shape the future of respiratory medicine within a company pioneering Generative Biology™. At Generate:Biomedicines, you’ll be part of a fast-moving, purpose-driven team translating cutting-edge science into meaningful therapies for patients.
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.
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.
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 USD - $279,000 USD
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.
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)
- Act as a key scientific contributor to late-stage protocols and regulatory submissions
- Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader
- Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
- Interpret clinical data in collaboration with cross-functional colleagues and external partners
- Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans
- Participate in data review and medical monitoring activities
- Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight
- Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
- 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
- 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
PhD, PharmD, MD or equivalent required; respiratory scientific background preferred
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
This is a unique opportunity to shape the future of respiratory medicine within a company pioneering Generative Biology™. At Generate:Biomedicines, you’ll be part of a fast-moving, purpose-driven team translating cutting-edge science into meaningful therapies for patients.
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.
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.
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 USD - $279,000 USD
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