Key Responsibilities
- Strategic clinical leader and clear voice for the ATTR amyloidosis clinical program.
- Develop realistic drug development approaches and lead clinical efforts to secure global regulatory approvals.
- Oversee trial conduct and safety.
- Provide strategic consultation to Research on clinical decisions and implications.
- Collaborate with Preclinical, Regulatory Affairs, and Medical Affairs to integrate product development plans.
- Own clinical research timelines and deliverables.
- Supervise major written deliverables (regulatory submissions, original articles, abstracts) and presentation materials.
- Final review/sign-off for controlled documents (protocols, investigator brochures, informed consent forms).
- Influence internal and external audiences; serve as external development spokesperson (e.g., regulatory and scientific meetings).
- Hybrid: 2 days/week onsite in Cambridge, MA or Philadelphia, PA.
Qualifications
- MD with strong research background or MD/PhD with best-in-class clinical and/or research training (supported by research support and peer-reviewed publications).
- Board Certification (or equivalent) or specialist training in cardiology.
- 3+ years industry or equivalent clinical academic experience.
- Sound scientific/clinical judgment; history of solving problems with balanced, realistic judgment.
- Knowledge of clinical research/clinical trial design (including biostatistics) and regulatory agency organization/guidelines.
- Ability to communicate complex medical/clinical concepts in writing and orally.
- Leadership and collaboration in a matrix environment.
- Experience working with biotech/pharma partners.
- Heart failure and/or amyloidosis expertise desirable.
Compensation/Benefits
- U.S. pay range: $255,000β$345,000; eligible for annual short-term incentive and annual long-term incentive.
- Comprehensive benefits: medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, and family resources/leave.