Senior Director, Clinical Science

Location
United States
Posted
Nov 03, 2020
Ref
43639288
Required Education
Doctorate/PHD/MD
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference.

If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

Summary

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 Clinical Science team seeks exceptional medical candidates at the Director level with substantial experience in clinical research. Background in cardiology (particularly with extensive cardiac imaging background) will be strongly considered.

The Position

The Sr Director, Clinical Science will initially support clinical development activities for 1 or more novel agents for targeted segments of heart disease under targeted Diastolic Dysfunction therapeutic area. This will include design and support for Phase 2 proof-of-concept study. Additionally, the successful candidate will be a key member of the TA leadership team and work closely with the TA lead to determine TA strategy for molecule development. Further, the candidate may provide support cross-functionally and across molecules related to cardiac disease states. This highly interactive and critical role will involve exposure to all aspects of clinical trial conduct. The Sr. Director will lead the development strategy and be directly involved in the design, implementation, monitoring, analysis and reporting of clinical trials and execution of activities to advance novel compounds into the clinic and through registration.

Principal Responsibilities
  • Contribute to strategic direction of TDD TA.
  • Lead and support the development of clinical study protocols, protocol amendments, imaging protocols and analysis plans, study guides, protocol training materials, and other clinical research related documents
  • Coordinate medical responses to support regulatory or IRB/Ethics Committee information requests
  • Lead and/or support clinical contribution to regulatory documents (INDs, IBs, Briefing documents, DSUR), clinical study reports and statistical analysis plans
  • Perform medical monitoring and/or oversee 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
  • Support 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, business development, and other stakeholders 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
  • M.D. or equivalent required, Board Certification desirable
  • Cardiology training with substantial experience with heart failure and/or other relevant cardiac disease states strongly preferred
  • 5-8 years minimum clinical development experience working in the regulated medical products industry or a substantial academic experience in clinical research 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