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Senior Medical Director Clinical Research
2 months ago
Lantheus Medical Imaging Inc is seeking a highly skilled Senior Medical Director Clinical Research to join our team. As a key member of our Clinical Development department, you will be responsible for overseeing the advancement of our neurology programs, devising clinical development strategies, and serving as a representative for Clinical Research on project-specific development teams.
Key Responsibilities:- Develop and execute clinical development plans, considering medical, scientific, regulatory, and commercial factors.
- Lead a multi-disciplinary clinical development team, making development decisions and integrating input from various disciplines.
- Apply clinical/medical decision-making to clinical development issues.
- Develop and implement clinical sub-team strategies and deliverables within the context of the Global Program Team's Asset Strategy.
- Responsible for performing and overseeing medical monitoring activities, assessing issues related to study execution and individual patient safety and well-being.
- Make high-impact decisions regarding study conduct, monitoring, and interpreting data from ongoing internal and external trials.
- Manage, mentor, motivate, empower, develop, and retain staff to support assigned activities.
- Contribute to and participate in interactions with regulatory authorities/agencies.
- Establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
- MD degree (or equivalent non-US medical degree), with current active board certification or active medical license (MD, PhD preferred).
- 5+ years of relevant experience in pharmaceutical industry in clinical development in neurology preferred.
- Clinical development experience across all phases of development (I - IV).
- Previous experience successfully leading a clinical development/matrix team.
- Proven track record of working with investigators, site staff, external experts, Contract Research Organizations, and vendors.
- Superior communication, strategic, interpersonal, and negotiating skills, effective leadership behavior, ability to drive decision making within a multi-disciplinary, matrix team.
- In-depth knowledge of regulatory guidelines and ICH/GCP.
- Experience in developing and writing study protocols, clinical study reports, and other study documents.
- Let people be their best.
- Respect one another and act as one.
- Learn, adapt, and win.
- Know someone's health is in our hands.
- Own the solution and make it happen.
Lantheus Medical Imaging Inc is an equal employment opportunity employer and is committed to diversity and inclusion. We welcome applications from qualified candidates without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
