Current jobs related to Medical Director, Clinical Research - Bedford - Lantheus

  • Senior Medical Director Clinical Research

    5 days ago

    Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Job Title: Senior Medical Director Clinical ResearchLantheus 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...

  • Senior Medical Director, Clinical Research

    3 months ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus 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...

  • Clinical Quality Assurance Director

    2 days ago

    Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Job Title: Clinical Quality Assurance DirectorLantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to innovation and quality. We are seeking a highly skilled Clinical Quality Assurance Director to join our team.Job Summary:The Clinical Quality Assurance Director will be responsible for ensuring the...

  • Director, Clinical Science

    4 months ago

    Bedford, United States Progenics Pharmaceutical Inc Full time

    Job DescriptionJob DescriptionLantheus 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...

  • Clinical Research Manager

    4 days ago

    Bedford, Massachusetts, United States Genabio Diagnostics Full time

    Job SummaryGenabio Diagnostics seeks a highly skilled Clinical Research Manager to oversee and perform clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, ISO standards, and local regulations.Duties and ResponsibilitiesConduct site qualification, initiation, interim monitoring, and close-out visits to...

  • Clinical Research Manager

    3 months ago

    Bedford, United States Genabio Diagnostics Full time

    Job SummaryThe clinical research Manager oversees and performs clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, ISO standards, local regulations, and Genabio’s SOPs. This position will develop and maintain collaborative relationships with investigational sites and work closely with project management...

  • Clinical Research Manager

    2 months ago

    Bedford, United States Genabio Diagnostics Full time

    Job SummaryThe clinical research Manager oversees and performs clinical monitoring and site management in accordance with ICH Good Clinical Practices, FDA guidelines, ISO standards, local regulations, and Genabio’s SOPs. This position will develop and maintain collaborative relationships with investigational sites and work closely with project management...

  • Global Medical Affairs Research Manager

    4 days ago

    New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Job Title: Global Medical Affairs Research ManagerLantheus Medical Imaging Inc is seeking a highly skilled Global Medical Affairs Research Manager to join our team. As a key member of our organization, you will be responsible for managing the Investigator Sponsored Trial program across our Medical Imaging portfolio.Key Responsibilities:Manage and monitor the...

  • Global Medical Affairs Research Lead

    4 weeks ago

    New Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time

    Position OverviewLantheus Medical Imaging Inc. is a leader in the field of medical imaging, dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions. With a rich history of over 60 years, we pride ourselves on our entrepreneurial spirit and commitment to excellence.Role SummaryThe Global Medical Affairs Research Manager...

  • Associate Director of Applications, AI-Digital Biomarker Solutions

    1 month ago

    Bedford, United States Lantheus Medical Imaging Inc Full time

    Job DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in Billerica and in 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...

  • Vice President, Medical Affairs Director

    3 weeks ago

    Bedford, Massachusetts, United States Lantheus Full time

    Job SummaryWe are seeking a highly experienced and skilled Vice President, Medical Affairs to lead our Medical Affairs function and contribute to the success of our organization.Key ResponsibilitiesLead and manage the Medical Affairs function, allocating and directing internal resources and effectively utilizing outsourcing to achieve project and business...

  • Associate Director, Clinical Operations

    3 months ago

    Bedford, United States Progenics Pharmaceutical Inc Full time

    Job DescriptionJob DescriptionLantheus 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...

  • Associate Director, Clinical Operations

    3 weeks ago

    Bedford, United States Progenics Pharmaceutical Inc Full time

    Job DescriptionJob DescriptionLantheus 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...

  • Director of Medical Science and Strategy

    3 weeks ago

    Bedford, Massachusetts, United States Progenics Pharmaceutical Inc Full time

    Job DescriptionJob Title: Vice President, Medical AffairsJob Summary:We are seeking a highly experienced and skilled Vice President, Medical Affairs to lead our Medical Affairs function. This individual will be responsible for developing and executing strategies to support the commercialization of our products, as well as providing medical and scientific...

  • Medical Director

    2 weeks ago

    Bedford, Massachusetts, United States VitalCore Health Strategies Full time

    Job SummaryVitalCore Health Strategies is seeking a highly skilled Medical Director to lead our correctional healthcare team. As a key member of our organization, you will be responsible for providing overall supervision of clinical services, ensuring the delivery of high-quality medical care to our patients.Key ResponsibilitiesProvide clinical leadership...

  • Chair and Medical Director

    5 days ago

    New Bedford, United States Sonic Healthcare USA Full time

    Chair and Medical DirectorNEW BEDFORD, MASSACHUSETTS (USA). University Pathologists (UPLLC), a Sonic Healthcare USA Partner, is recruiting for an Anatomic and Clinical Pathologist to be the Chair and Medical Director of our three-hospital system (non-academic). This position has clinical administrative responsibilities. Candidate will be experienced in blood...

  • Chair and Medical Director

    5 days ago

    New Bedford, United States Sonic Healthcare USA Full time

    Chair and Medical DirectorNEW BEDFORD, MASSACHUSETTS (USA). University Pathologists (UPLLC), a Sonic Healthcare USA Partner, is recruiting for an Anatomic and Clinical Pathologist to be the Chair and Medical Director of our three-hospital system (non-academic). This position has clinical administrative responsibilities. Candidate will be experienced in blood...

  • Associate Director of Applications, AI-Digital Biomarker Solutions

    1 month ago

    Bedford, United States Lantheus Full time

    Lantheus is headquartered in Bedford, Massachusetts with offices in Billerica and in 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...

  • Clinical Director

    2 weeks ago

    New Bedford, Massachusetts, United States FCS, Inc Full time

    Clinical Director OpportunityFCS, Inc is seeking a highly experienced Licensed Clinical Social Worker to fill the role of Clinical Director at our Mental Health Center in New Bedford. This is a full-time position with the possibility of remote work or a hybrid model after a 90-day introductory period.Key Responsibilities:Provide clinical supervision to staff...

  • Animal Research Technician

    2 months ago

    Bedford, United States Labcorp Full time

    Do you have experience as a Vet Tech caring for animals? Are you a CVT or RVT or LVT? This is the job for you! Change you career direction into Research!Join a cohesive team and an exceptional organization!We have an Animal Research Technician position in Bedford, MA, Apply Now!This is an exceptional opportunity with an Exceptional Organization! The...

Medical Director, Clinical Research

3 months ago

Bedford, United States Lantheus Full time

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

The Medical Director Clinical Research will report to the Senior Medical Director, Clinical Research and 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 Functions

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, 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, Clinical Scientists, Medical Directors, 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 (e.g. 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 Head of 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

Actively demonstrates the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

Typical Minimum Skills and Experience and Education

MD Degree required board certification in the therapeutic area of interest is a nice to have

7 - 10 years of relevant experience in pharmaceutical industry in clinical development operations

Neurology and/or medical imaging clinical development experience

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

Other Requirements

Routine overnight travel based on business need.

Core Values:

The ideal candidate will embody Lantheus core values:

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

#LI-HYBRID

#J-18808-Ljbffr