About the job
Medical Director/Clinical Development Physician – Musculoskeletal
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company.
Come join us make a significant difference in the lives of patients!
About the Position:
The Medical Director will provide Clinical Development support across musculoskeletal clinical development with a focus in BMD and DMD. In this capacity, this individual will closely collaborate with cross-functional partners in clinical operations, statistics, regulatory, medical writing and medical affairs to support design and execution of innovative development plans for programs spanning the full lifecycle of development. In addition, this role will support efforts to optimize efficiencies, data analysis, novel endpoint development and regulatory engagements/submissions.
Provides clear medical input in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.
Essential Job Duties and Functions:
- Provide clinical functional representation to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials.
- Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early and discussed with the CRO Medical Monitor;
- Collaborate on clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the VP Clinical Development
- Medical point of contact for internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material internally, as well as to the data monitoring committee, scientific advisory board, investigator meetings and congresses/scientific meetings as applicable;
- Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
- Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
- Perform other duties as assigned by supervisor.
Required Education, Experience and Skills:
- Medical Doctor (MD)
- 5 years experience in late-stage clinical development
- Neuromuscular expertise
- Proven interpersonal skills enabling to lead a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately
- Pro-active problem solver with negotiation skills
- Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties
Salary range: $260,000 - $330,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
