Medical Director/Clinical Development Physician – Musculoskeletal
Edgewise Therapeutics
2 months ago
Remote friendly (United States)
United States
Clinical Research and Development
Medical Director/Clinical Development Physician – Musculoskeletal
About the Position:
- Provide Clinical Development support across musculoskeletal clinical development with a focus in BMD and DMD.
- Collaborate with cross-functional partners (clinical operations, statistics, regulatory, medical writing, medical affairs) to design and execute innovative development plans across the full lifecycle of development.
- Optimize efficiencies, data analysis, novel endpoint development, and regulatory engagements/submissions.
- Provide clear medical input to the study team to deliver reliable, high-quality study data within time and budget.
Essential Job Duties and Functions:
- Provide clinical functional representation to study teams, including creating clinical trial protocols, contributing to site selection, and reviewing/approving study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents.
- Provide real-time medical monitoring to ensure medical validity of primary endpoints and subject safety; identify medical issues early and discuss with the CRO Medical Monitor.
- Collaborate on clinical trial data for regulatory documents (e.g., CSRs, INDs, annual reports, NDAs, MAAs), manuscripts, and publications (in consultation with the VP Clinical Development).
- Serve as medical point of contact for internal/external stakeholders, including interactions with investigators, IRBs and Health Authorities, and presenting materials to committees and meetings.
- Ensure medical study compliance by understanding and applying relevant SOPs and GCP.
- Collaborate with cross-functional teams so medical risks, issues, and results are clear to all involved parties.
- Read, understand, and comply with workplace health and safety policies and company policies/procedures.
- Perform other duties as assigned.
Required Education, Experience and Skills:
- Medical Doctor (MD)
- 5+ years of experience in late-stage clinical development
- Neuromuscular expertise
- Proven interpersonal skills to lead a study team; provide medical advice/evaluations and escalate issues requiring immediate action
- Proactive problem-solving and negotiation skills
- Strong communication skills to ensure transparent collaboration and clarity on risks, issues, and results
Benefits / Compensation:
- Salary range: $260,000–$330,000 (commensurate with experience)
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) match, paid time off
Application Instructions:
- Applications are accepted on an ongoing basis; no deadline is specified.
- Edgewise does not accept resumes from recruitment agencies; do not send resumes to Edgewise employees or the company location.
About the Position:
- Provide Clinical Development support across musculoskeletal clinical development with a focus in BMD and DMD.
- Collaborate with cross-functional partners (clinical operations, statistics, regulatory, medical writing, medical affairs) to design and execute innovative development plans across the full lifecycle of development.
- Optimize efficiencies, data analysis, novel endpoint development, and regulatory engagements/submissions.
- Provide clear medical input to the study team to deliver reliable, high-quality study data within time and budget.
Essential Job Duties and Functions:
- Provide clinical functional representation to study teams, including creating clinical trial protocols, contributing to site selection, and reviewing/approving study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents.
- Provide real-time medical monitoring to ensure medical validity of primary endpoints and subject safety; identify medical issues early and discuss with the CRO Medical Monitor.
- Collaborate on clinical trial data for regulatory documents (e.g., CSRs, INDs, annual reports, NDAs, MAAs), manuscripts, and publications (in consultation with the VP Clinical Development).
- Serve as medical point of contact for internal/external stakeholders, including interactions with investigators, IRBs and Health Authorities, and presenting materials to committees and meetings.
- Ensure medical study compliance by understanding and applying relevant SOPs and GCP.
- Collaborate with cross-functional teams so medical risks, issues, and results are clear to all involved parties.
- Read, understand, and comply with workplace health and safety policies and company policies/procedures.
- Perform other duties as assigned.
Required Education, Experience and Skills:
- Medical Doctor (MD)
- 5+ years of experience in late-stage clinical development
- Neuromuscular expertise
- Proven interpersonal skills to lead a study team; provide medical advice/evaluations and escalate issues requiring immediate action
- Proactive problem-solving and negotiation skills
- Strong communication skills to ensure transparent collaboration and clarity on risks, issues, and results
Benefits / Compensation:
- Salary range: $260,000–$330,000 (commensurate with experience)
- Health benefits, discretionary bonus plan, stock option grants, stock purchase plan, 401(k) match, paid time off
Application Instructions:
- Applications are accepted on an ongoing basis; no deadline is specified.
- Edgewise does not accept resumes from recruitment agencies; do not send resumes to Edgewise employees or the company location.