Senior Medical Director, Clinical Research - Neurology
LantheusAbout the role
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. With revenues exceeding $1B in 2023, the company is in the process of developing a pipeline of radiopharmaceuticals for both imaging and therapy of cancers, Alzheimers, and other serious illnesses. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
The Senior Medical Director Clinical Research will report to the Head of Clinical Development and will oversee the assigned clinical development activities. They will be responsible for assisting with the advancement of specific neurology programs by devising clinical development strategies and by serving as a representative for Clinical Research on project-specific development teams. The successful candidate will have wide-ranging responsibilities and the ability to work within a highly collaborative, dynamic, and interdisciplinary team.
Essential Functions
- Responsible for the overall clinical development, taking into consideration the medical, scientific, regulatory, and commercial considerations for assigned pipeline products.
- Leads a multi-disciplinary, matrix clinical development team with responsibility for development decisions, assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan.
- Applies clinical/medical decision making to clinical development issues.
- May serve as Clinical leader of individual therapeutic programs.
- Develops Clinical Sub-Team strategy and deliverables in the context of the Global Program Team’s Asset Strategy; works collaboratively to generate the Clinical Development Plan and Clinical Protocols and is accountable for the successful design and interpretation of clinical studies.
- Responsible for performing and overseeing medical monitoring activities, assessing issues related to the study execution and individual patient`s safety and well-being, in partnership with the CRO responsible for trial delivery. Assesses overall safety information and risk-benefit information for studies and compounds in conjunction with Pharmacovigilance.
- Responsible for high impact decisions: monitoring and interpreting data from ongoing internal and external trials, assessing the medical and scientific implications, and making recommendations that impact development. Makes final decisions regarding study conduct related to scientific integrity.
- Manages, mentors, motivates, empowers, develops, and retains staff to support assigned activities. Conducts performance reviews and drives goal setting, and development planning. Coordinates, leads, and delivers periodic departmental training.
- Contributes to and participates in the activities related to interactions with the regulatory authorities/agencies.
- Establishes and maintains strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
- Interacts and collaborates with Medical Affairs in relation to Investigator-Sponsored Trials and collaborative trials.
- Responsible for evaluation of potential business development opportunities, conducts due diligence evaluations, and contributes to the development plans for potential alliances and/or in-licensing opportunities.
- Serves as the clinical contact for ongoing alliance and collaboration projects, and interfaces with partners to achieve Lantheus’s strategic goals while striving to maintain good working relationships between Lantheus and partner.
- Attends scientific meetings to remain abreast of clinical developments, interacts with investigators, and advisors
Typical Minimum Skills, Experience and Education
- MD degree (or equivalent non-US medical degree), (current active board certification or active medical license is not required; MD, PhD preferred)
- 5+ years of relevant experience in pharmaceutical industry in clinical development in neurology preferred
- Clinical development experience across all ph
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