Senior Director/Medical Director, Clinical Trial Lead
$242,000–$347,000 year
On-sitePrinceton, New Jersey, United States
Job Summary
Lead clinical development strategy for phase 1-3 trials, including protocol design, operational planning, and execution. Manage medical, safety, and data monitoring while overseeing site selection, activation, recruitment, and close-out activities. Author and review regulatory submissions, briefing documents, and Investigational Brochures, and lead clinical responses to regulatory and IRB inquiries. Collaborate with academic partners, statisticians, and cross-functional teams to develop statistical analysis plans and interpret final results. Present scientific findings at advisory boards, academic committees, and key meetings, ensuring consistency of clinical messages across publications. Contribute to target product profile and global product safety plans.
Required Qualifications
- MD, or equivalent medical degree
- cardiology specialty training
- cardiology board certification
- Minimum 10 years' clinical development experience working cross-functionally in the regulated medical products industry
Desired Qualifications
- experience with preparation of and submissions of INDs and NDAs
- Experience leading and motivating teams in a matrix environment
- Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams
- Ability to develop and execute complex strategies
- Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets
- Skilled in establishing a collaborative and respectful environment
- Demonstrated ability to lead a matrixed team through influence
- Proven track record of influence strategy, initiative(s) implementation, and decision-making
- Proactively influences and motivates others to achieve objectives
- Strong decision-making skills taking multiple perspectives into account and analytical skills
- exercises sound business judgment that has broad organizational impact
- Excellent communication skills (both orally and written)
- Good at developing the processes necessary to get things done, knowing how to organize people and activities, and knowing what to measure and how to measure
- Demonstrated ability to interpret data into actionable items
- Proven negotiation skills that effectively drive discussions and decisions to desired end results that have broad organizational impact
- Proven track record of achieving alignment with internal and external stakeholders
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