- Independently manages tracks and monitors the Global Investigator Sponsored Trial program across all Lantheus assets and ensure that compliance with SOPs is documented for all processes within the assigned portfolio.
- Interfaces with physicians and scientists for study conduct and regulatory compliance for investigator sponsored trials in a global environment. This includes all facets of the process across multiple functional areas from concept development through to publication and dissemination of findings.
- Ensures IST study files meet GCP requirements, regulatory requirements (including drug accountability) and accurately reflect the content and status of all IST's.
- Ensures the preparation of new IST applications for review by Research Review Committee (RRC) for all pre-clinical and clinical IST protocols.
- Interact as needed with investigators, applicants and site staff as needed to effectively review and implement IST proposals.
- Interface with Pharmacovigilance function, external business partners and distributors to promote strategic alignment & safety requirements for marketed products involved in the IST program.
- Support the IST agreement (contract) process for all IST's, in collaboration with medical, legal, and regulatory functions.
- Support activities to drive adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.
- Integrates a range of data and input from multiple sources and collaborate effectively across multidisciplinary work teams required to review, assess and accurately document IST program content.
- Provides updates to all relevant departments (e.g., R&D, marketing, customer service, business development) as needed.
- Ensures adequate understanding of IST research content and requirements to be able to fluently interact with Lantheus staff, external investigators, and site staff.
- Develops and maintains knowledge of regulatory and operational aspects of the management of clinical trials in all countries where ISTs are located.
- Ensures accurate reporting on progress, milestone achievement and issues to upper management. Recognizes and escalates to appropriate personnel significant issues relating to compliance, timelines or other issues that jeopardize business objectives.
- Actively demonstrates and promotes the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
- Manages multiple competing responsibilities and adapt to continually shifting priorities and day to day demands.
- Bachelor's degree or equivalent in a scientific or health related field required. Advanced healthcare professional degree (e.g., PharmD, PhD, DO or MD or equivalent strongly preferred).
- Knowledge of medical imaging field and diagnostics agents preferred. Project management training or one or more years of experience. Working knowledge of current ethical, GCP and regulatory guidelines.
- Minimum 3 years' experience in Investigator Sponsored Trials and/or Clinical Trial Operations, in post marketed products.
- Typically requires 2 + years of related professional industry experience.
- Knowledge/training in prostate cancer therapy and imaging agents an advantage.
- Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form.
- Occasional travel based on educational or business purposes
- 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
Global Medical Affairs Research Manager - Billerica, United States - Lantheus
Description
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. 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.
Summary of Role
Manage the Investigator Sponsored Trial program across the Lantheus Medical Imaging portfolio for all Lantheus assets, including all processes related to multiple functional areas.
Essential Functions
Typical Minimum Skills and Experience and Education
Other Requirements
Core Values:
The ideal candidate will embody Lantheus core values:
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