- Responsible for the relevance and accuracy of clinical science planning and guidance for a clinical study (e.g., study concepts/synopsis/study protocol development by translating the clinical development strategy into efficient clinical protocol and related documents
- Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables, including but not limited to Clinical Protocols and amendments, Investigator Brochures, Study Manuals, Case Report Forms, Informed Consent Forms, Clinical Study Reports, Annual Reports, regulatory submissions, abstracts and publications
- Responsible for the oversight of clinical study execution in close collaboration with Clinical Operations lead, internal and external stakeholders (data management, biostatistics, programming, drug safety and PV, medical imaging, medical writing, research and discovery)
- Works with investigative sites and/or study teams to answer protocol related questions, resolve study conduct issues
- Reviews clinical data listings, patient profiles and summaries to ensure data collection, data interpretation and data reporting proceeds in a manner consistent with the protocol, company processes/procedures and strategic objectives
- Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
- Works closely with internal and external stakeholders to accumulate scientific and clinical knowledge necessary to support clinical development execution of clinical protocols and data collection
- Supports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions including but not limited to briefing documents, presentation materials, and IND/NDAs
- Participates in review and management of safety reports and submissions
- Participate in clinical and safety database reconciliation
- Supports project team with conduct of clinical studies including clinical trials registration and results reporting, and in the monitoring and analysis of emerging clinical data and safety data trends. May be consulted in data management deliverables, clinical monitoring activities, interim analyses planning and Data Safety Monitoring Board or Steering Committee meetings as applicable
- Interacts with internal and external stakeholders (Key Opinion Leaders, Medical Director, vendors, committees) in support of clinical trial objectives and deliverables, including investigator-sponsored trials
- Leads preparation of advisory board meetings, and KOL interactions; leads development of clinical publications (eg. presentations at scientific meetings)
- Works with external experts to develop abstracts, manuscripts and study design presentations
- Works in a strategic and facilitative role by leveraging clinical development expertise in providing support to the Senior Medical Director Clinical Research
- Serves as clinical representative on product development team
- Leads drug development team across a complex, matrixed environment. Communicate a vision and strategy for this multidisciplinary team
- Attends scientific meetings to remain abreast of clinical developments, interact with investigators, and advisors
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards
- Advanced Degree preferred (e.g. MS, PhD, or PharmD)
- Oncology and neuroscience medical imaging and/or Radiopharmaceutical clinical development experience preferred
- Clinical development experience across all phases of development (I - IV)
- Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
- In depth knowledge of regulatory guidelines and ICH/GCP
- Experience in developing and writing study protocols, clinical study reports and other study documents
- Excellent verbal and written communication skills with ability to work across functions in multifunctional matrix environment
- Routine overnight travel based on business need
- 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
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Director, Clinical Science - Bedford, United States - Lantheus Holdings, Inc.
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 have helped physicians enhance patient care with our 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.
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 skills sets to be a part of a productive and inclusive team.
The Director, Clinical Science will be responsible for the design and interpretation of Lantheus clinical studies, including protocol development and oversight.
This position has a key role in clinical development and supports progression of the investigational product from IND through registration, the position will operate in a cross-functional matrix environment and work with multiple functional groups.
The successful candidate will have wide-ranging responsibilities and the ability to work within a highly collaborative, dynamic, and interdisciplinary team.
Essential FunctionsThe ideal candidate will embody Lantheus core values:
