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We are Hiring
Director,
Clinical Science
for
Director, Clinical Science
Waltham, Massachusetts
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.
Position Responsibilities
- 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.
Basic Requirements
- Advanced Degree preferred (e.g. MS, PhD, or PharmD).
- 7 - 10 years of relevant experience in pharmaceutical industry in clinical development operations preferred.
- 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.
Know About
About
Lantheus
Lantheus is recognized as an entrepreneurial and agile organization dedicated to delivering innovative diagnostics, targeted therapeutics, and AI solutions. Their cutting-edge technologies empower clinicians to find, fight, and follow diseases effectively. Guided by a strong set of purposes and values, Lantheus fosters behaviors in all interactions that contribute significantly to their dynamic and successful environment.
The company emphasizes the importance of each employee, promoting a culture of respect and unity with the understanding that they play a crucial role in someone’s health. Lantheus is committed to helping individuals achieve their best and strives to bring together a diverse group of professionals with varied perspectives and skills. This diversity is key to creating a productive and inclusive team.
Product
Pipeline
Lantheus Holdings, Inc. is a global leader in developing, manufacturing, and commercializing diagnostic and therapeutic products designed to aid clinicians in diagnosing and treating heart conditions, cancer, and other diseases. Their portfolio includes:
- DEFINITY: An ultrasound enhancing agent used in echocardiography exams.
- TechneLite: A technetium generator for nuclear medicine.
- Xenon-133: Utilized to assess pulmonary function.
- Neurolite: Identifies brain areas where blood flow is blocked or reduced due to stroke.
- Cardiolite: An injectable Tc-99m-labeled imaging agent.
- PYLARIFY: Visualizes lymph nodes, bone, and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
Notable
Articles
- Lantheus Acquires NAV-4694, a Next-Generation ß Amyloid PET Imaging Agent for Alzheimer’s Disease
- Lantheus Welcomes CMS’ Proposed CY25 Rule for Improved Payment for Specialized Diagnostic Radiopharmaceuticals to Support Patient Access
- Lantheus Acquires Global Rights to Life Molecular Imaging’s Novel Therapeutic and Diagnostic Pair Targeting GRPR for Prostate and Breast Cancers
- Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients
- Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer
We work with you to uncover your career goals and talents to find the ideal fit.
Recruitment Team
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