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About Generate:Biomedicines
Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential togenerate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.
About 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 VP, Respiratory Product Leader.Here's how you'll 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)
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
What You’ll Need (Qualifications)
- Advanced degree (PhD, PharmD, MD, MS, PMP ) required 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
Education
PhD, PharmD, MD or equivalent required; respiratory scientific background preferredNice 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.
Why Join Us
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.#LI-KD1
#LI-RT1
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
—$279,000 USD
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