Jobs
>
Bedford

    Medical Director, Clinical Research - Bedford, United States - Lantheus

    Lantheus
    Lantheus Bedford, United States

    3 weeks ago

    Default job background
    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 RoleThe 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 FunctionsResponsible 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 documentsContribute 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 publicationsResponsible 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 issuesReviews 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 objectivesPrepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settingsWorks closely with internal and external stakeholders to accumulate scientific and clinical knowledge necessary to support clinical development execution of clinical protocols and data collectionSupports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions including but not limited to briefing documents, presentation materials, and IND/NDAsParticipates in review and management of safety reports and submissionsParticipate in clinical and safety database reconciliationSupports 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 applicableInteracts 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 trialsLeads 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 presentationsWorks in a strategic and facilitative role by leveraging clinical development expertise in providing support to the Head of Clinical ResearchServes as clinical representative on product development teamLeads drug development team across a complex, matrixed environment.

    Communicate a vision and strategy for this multidisciplinary teamAttends scientific meetings to remain abreast of clinical developments, interact with investigators, and advisorsActively 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 hazardsActively 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- 10 years of relevant experience in pharmaceutical industry in clinical development operationsNeurology and/or medical imaging clinical development experienceClinical development experience across all phases of development (I - IV)Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendorsIn depth knowledge of regulatory guidelines and ICH/GCPExperience in developing and writing study protocols, clinical study reports and other study documentsExcellent verbal and written communication skills with ability to work across functions in multifunctional matrix environmentOther RequirementsRoutine overnight travel based on business need.


    Core Values:
    The ideal candidate will embody Lantheus core values:Let people be their bestRespect one another and act as oneLearn, adapt, and winKnow someone's health is in our handsOwn the solution and make it happen
  • Massachusetts General Hospital(MGH)

    Clinical Research Assistant

    3 weeks ago

    Massachusetts General Hospital(MGH) Boston, United States

    **Clinical Research Assistant** · GENERAL SUMMARY/ OVERVIEW STATEMENT · Research Assistant I will perform experiments and record data in a translational neuroscience research laboratory. · PRINCIPAL DUTIES AND RESPONSIBILITIES: · - Collects and organizes experimental data · - Mai ...

  • Brigham & Women's Hospital(BWH)

    Clinical Research Assistant, Center for Clinical

    3 weeks ago

    Brigham & Women's Hospital(BWH) Boston, United States

    **Clinical Research Assistant, Center for Clinical Investigation, Hybrid** · **GENERAL SUMMARY/ OVERVIEW STATEMENT**: · Working under general supervision from a manager, lead coordinator or Principal Investigator, provides support to clinical research studies. May be responsible ...

  • Boston Children's Hospital

    Clinical Research Assistant I

    3 weeks ago

    Boston Children's Hospital Boston, United States

    74629BR · - Medicine-GI/Nutrition · **Job Posting Description** · - Responsibilities span many aspects of study design and network collaboration, and may include: coordinating the collection of data and informed consent, interacting with the Institutional Review Board (IRB), assi ...

  • Boston Children's Hospital

    Clinical Research Specialist I

    2 weeks ago

    Boston Children's Hospital Boston, United States

    75356BR · - Medicine-Genetics · **Job Posting Description** · - This Research Specialist will support clinical research in rare genetic conditions by facilitating online enrollment, online, remote and in person data collection, collection of medical records, and collection of bio ...

  • Tufts Medical Center

    Clinical Research Associate I

    3 weeks ago

    Tufts Medical Center Boston, United States

    We're saving lives, building careers, and reimagining healthcare. We can't wait to grow alongside you. · **Job Profile** Summary** · This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In ...

  • Lantheus Holdings, Inc.

    Medical Director, Clinical Research

    1 week ago

    Lantheus Holdings, Inc. Bedford, United States

    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. · ...

  • Massachusetts General Hospital

    Clinical Research Coordinator

    1 week ago

    Massachusetts General Hospital Lexington, United States

    GENERAL SUMMARY/ OVERVIEW STATEMENT: · The Lurie Center for Autism, a Mass General Brigham program based in Lexington, is a multidisciplinary program designed to evaluate and treat children, adolescents and adults with autism spectrum disorder (ASD). The Center is seeking a Resea ...

  • Lantheus

    Medical Director, Clinical Research

    3 weeks ago

    Lantheus Bedford, MA, United States

    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

    Medical Director, Clinical Research

    1 week ago

    Lantheus Bedford, United States

    · 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 ...

  • BRIOHEALTH SOLUTIONS INC

    Clinical Research Associate I

    1 week ago

    BRIOHEALTH SOLUTIONS INC Boston, United States

    Duties and responsibilities include the following. · - Set up and maintenance of study files, including administration of the eTMF where used in clinical studies and supporting any use of CTMS · - Drafting and review of participant information sheets and informed consents · - Rev ...

  • Lantheus

    Medical Director, Clinical Research

    2 weeks ago

    Lantheus Bedford, United States

    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

    Medical Director, Clinical Research

    3 weeks ago

    Lantheus Bedford, United States

    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. ...

  • Beth Israel Lahey Health

    Clinical Research Specialist

    1 week ago

    Beth Israel Lahey Health Burlington, United States

    Job Type: Regular · Time Type: Full time · Work Shift: Day (United States of America) · FLSA Status: Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shif ...

  • Beth Israel Lahey Health

    Clinical Research Specialist

    2 weeks ago

    Beth Israel Lahey Health Burlington, United States

    When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · Job Type: · Regular · Scheduled Hours: · 40 · Work Shift: · Day (United States of America) · Job Description: · Position Summary: Coordinates multiple research studi ...

  • Beth Israel Lahey Health

    Clinical Research Specialist

    3 weeks ago

    Beth Israel Lahey Health Burlington, United States

    **When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.****Job Type:**Regular**Scheduled Hours:**40**Work Shift:**Day (United States of America)**Job Description:****Position Summary:** Coordinates multiple research studi ...

  • Beth Israel Lahey Health

    Clinical Research Specialist

    1 week ago

    Beth Israel Lahey Health Burlington, United States

    **Job Type:** Regular**Time Type:** Full time**Work Shift:** Day (United States of America)**FLSA Status:** Exempt**When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.****Job Type:**Regular**Scheduled Hours:**40**Work S ...

  • Insulet

    Clinical Research Associate

    1 week ago

    Insulet Billerica, United States

    The Clinical Research Associate is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required. Responsibilities Collaborate with team members in the evaluation and e Research, Associate, Manufact ...

  • Boston Children's Hospital

    Clinical Research Assistant I

    1 week ago

    Boston Children's Hospital Boston, United States

    75334BR · - Medicine-General Pediatrics · **Job Posting Description** · - The Program for Patient Safety and Quality (PPSQ) and the Center of Excellence for Pediatric Quality Measurement (CEPQM) at Boston Children's Hospital is looking for an enthusiastic, intelligent, and organi ...

  • Partners Healthcare System

    Clinical Research Coordinator II

    1 week ago

    Partners Healthcare System Lexington, United States

    GENERAL SUMMARY/ OVERVIEW STATEMENT: · Williams syndrome (WS) is a rare genetic disorder which is associated with a broad array of medical, developmental, and behavioral/emotional issues. The Williams Syndrome Program, a cooperative program between the Lurie Center and Massachuse ...

  • Takeda Pharmaceuticals

    Associate Director, Clinical Research

    5 days ago

    Takeda Pharmaceuticals Lexington, United States

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...