Senior Director, Clinical Development Medical Lead (Asthma and COPD)
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Job Location:
Somerville, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 to generate 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.
We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions with an outsized opportunity for patients in need. We are seeking collaborative relentless problem solvers that share our passion for impact to join us!
Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover Massachusetts with 300 employees.
*** The addition of a cover letter with ahigh-leveloverview of your directexpertisein leadinglate-stageclinical trials in asthma and/or COPD would begreatly appreciated***
The Role:
Generate:Biomedicinesisseekinga strategic and experienced Senior Director to lead clinical development and medical monitoring for our late-stage asthmaand COPDprograms.This individual will report to theVice Presidentof Clinical Development and serve as the medical lead for global asthma trials ensuring scientific rigor patient safety and executional excellence. The ideal candidate is an MD with deep respiratoryexpertiseand a passion for transforming asthmaand COPDcare through innovative biologics.
Heres how you will contribute:
- MedicalLeadforthe Clinical Development Team (CDT) to deliver Phase 3 asthmaand COPDstudies
- Provide medical leadership and oversight for late-stage clinical trials in asthmaand COPD
- Develop and refine clinical strategies and Target Product Profiles (TPPs) specific to asthmaand COPD
- Serve as key author of late-stage clinical protocols aligned with regulatory requirements
- Author clinical and scientific content for regulatory submissions (e.g. BLA MAA)
- Oversee study design protocol development data review and safety monitoring
- Perform medical monitoring for late-stage studies ensuring patient safety protocol compliance and data integrity
- Serve as a member of the Safety Management Team (SMT)
- Collaborate cross-functionally with Clinical Operations Regulatory Biostatistics and Pharmacovigilance
- Serve as primary medical contact for clinical sites investigators and CROs
- Interpret clinical trial data and contribute to study reports regulatory filings and publications
- Represent Generate at internal and external scientific and medical meetings
- Engage with external experts advisory boards and health authorities to support program goals
Leadership Responsibilities
- Hold teams tohigh standardsfor technical and collaborative performance
- Foster a high-performing diverse and inclusive team culture
- Promote enterprise thinking and strategic alignment across functions
- Communicate with clarity courage and empathy
- Model resilience adaptability and informed risk-taking
The Ideal Candidate will have:
- MD (required); board certification in Pulmonology orAllergy & Immunologypreferred
- 8 years of clinical development experience in the biopharma industry
- Extensiveexpertisein asthma and respiratory clinical trial design
- Experience leading late-stage trials and engaging with regulatory bodies
- Strong cross-functional leadership and communication skills
- Proven ability to collaborate with internal teams and external stakeholders
Education
MDrequired;additionalscientific training (e.g. fellowship MPH) a plus
Nice to Have (Optional)
- Experience in both large pharma and biotech settings
- Familiarity with global regulatory frameworks (e.g. FDA EMA)
- Prior involvement in successful BLA or MAA submissions
Who Will Love This Job:
This is an exciting opportunity to shape the future of asthma care by advancing novel biologics using the power of generative biology. AtGenerate:Biomedicinesyoulljoin a mission-driven team committed to scientific excellence!
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 Companys 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.
#LI-RT1
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 addition you will be eligible for an annual bonus equity compensation and a competitive benefits package.
Required Experience:
Exec
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
Generate Biomedicines is a new kind of therapeutics company—existing at the intersection of biology, machine learning, and biological engineering.
