Senior Director, Clinical Science (MD)

Location
United States
Posted
Nov 03, 2020
Ref
805236520
Required Education
Bachelors Degree
Position Type
Full time
MyoKardia is passionate about breakthrough science and transforming the treatment of genetic heart disease through a targeted medicine approach. Our clinical programs in cardiomyopathies and related indications are advancing leading to growth in our Clinical Development organization. The MyoKardia Clinical Science team seeks exceptional medical candidates at the Senior Director level with experience in clinical development. Background in cardiology, internal medicine, genetics, or rare disease will be strongly considered.

The Position

The Senior Director, Clinical Science position will initially involve clinical development activities with a novel agent for hypertrophic cardiomyopathy (HCM) currently in a Phase1 clinical trial with subsequent opportunity to lead one or more exploratory Phase 2 studies. This highly interactive and critical clinical study lead role involves all aspects of clinical trial conduct. The Director will be directly involved in the design, implementation, monitoring, analysis and reporting of domestic and global clinical trials and executing all activities to advance novel compounds into the clinic and through registration.

Principal Responsibilities
  • Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other clinical research related documents
  • Coordinate medical responses to support regulatory or IRB/Ethics Committee information requests
  • Lead clinical contribution to regulatory documents (INDs, IBs, Briefing documents, DSUR), clinical study reports and statistical analysis plans
  • Perform medical monitoring (safety data review and identify potential signals), responses to site inquiries, and work with CRO medical monitors when appropriate
  • Take medical responsibility in data analysis and interpretation, reporting and communication - ensure consistency and relevance of medical content and scientific messages across written materials
  • Lead the operational aspects of study conduct and patient enrollment efforts including participation in site training, initiation and activation and subsequent site engagement activities
  • Maintain focus on robust study conduct and quality data generation
  • Contribute to strategic planning of clinical development plan and represent clinical science on study teams
  • Collaborate cross-functionally internally and externally with investigators, Key Opinion Leaders, advisors, consultants, contractors and CROs
  • Collaborate with research, translational research, medical affairs, and business development on cross-functional initiatives
  • Participate in the preparation of abstracts, posters and presentations for scientific meetings and congresses
  • Travels periodically to conferences, investigator meetings and individual sites as needed


Education/Experience
  • MD. required, Board Certification desirable
  • 4-6 years minimum clinical development experience working in the regulated medical products industry with a strong track record in working well with teams
  • Excellent communication and collaboration skills and experience working in cross-functional groups
  • Experience communicating and interacting with investigators, KOLs, and advisors
  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance
  • Ability to work collaboratively with cross-functional team to support management of large volumes of data
  • Ability to operate and thrive in a fast-paced environment; demonstrated flexibility
  • Demonstrated success of taking initiative in a team setting
  • Comfortable with ambiguity, yet be self-motivated and timeline driven
  • Ability to travel up to 15% as needed