Director/Sr Director, Data Management
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 Director/Sr Director, Data Management is responsible for the oversight of data management activities in support of Edgewise Therapeutics’ studies across all stages of clinical drug development. This is primarily a leadership position with additional hands-on DM study tasks as needed. The Director/Sr Director of Data Management will report to the VP of Biometrics.
Essential Job Duties and Functions:
- Collaborates with Sr. Leadership, study team, and vendors to ensure that data management deliverables are of high-quality, and milestones are achieved on-time
- Oversees DM staff and is responsible for their development
- Represents DM in internal and external meetings in a leadership capacity
- Advises on best practices for DM and serves as an escalation path for data management decisions
- Participates in vendor selection and contract negotiation process, including RFPs and bid defense meetings, as applicable
- Participates as subject matter expert during regulatory inspections and/or vendor audits
- Provides guidance in the authoring, review and/or approval of study related documents and plans
- Contributes to the development of Data Management SOPs and Working Instructions, and cross-functional SOPs, as applicable
- Oversees EDC development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)
- Provides oversight of external data providers, including data reconciliation activities
- Oversees the conduct of clinical data review and preparation for DMC, DSUR, Database Freeze, Database Lock and/or other data deliverables
- Coordinates and/or provides training on EDC systems and reporting tools
- Ensures adherence to ICH GCP Guidelines, GCDMP, and CDISC guidelines and requirements
- May act as assigned internal lead DM to one or more outsourced studies
- Manage/perform other duties as needed
Required Education, Experience and Skills:
Required qualifications:
- B.S. in a scientific field with 10+ years of data management experience in CRO/pharma/biotech setting
- Proficient in clinical data collection, cleaning, and analysis for clinical trials; cardiology and/or musculoskeletal indications experience is a plus
- Experience with a variety of EDC systems
- Solid understanding of GCDMP and CDASH
- Knowledge of regulatory requirements for data submissions
- Experience auditing data vendors and clinical systems
- The willingness to contribute to the day-to-day DM activities at all levels as needed, from data cleaning to leading a department
Desired qualifications:
- Interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills
- Ability to self-motivate and lead with confidence is critical
- Excellent organizational and time management skills, sense of urgency
- Strong analytical and problem-solving skills
- Project Management skills
This is a remote position.
Salary range: $170,000-$230,000, 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.