Current jobs related to Associate Director Clinical Sciences Oncology - Basking Ridge, New Jersey - BioSpace, Inc.

  • Associate Director Clinical Science

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Clinical ScienceAt Daiichi Sankyo, Inc., we are seeking an experienced Associate Director, Clinical Science to join our team. This role will oversee the strategic direction of clinical trials, providing medical and scientific guidance to Clinical Operations. The successful candidate will have a strong background in clinical...

  • Associate Director, Clinical Science

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Clinical ScienceAbout the Role:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Clinical Science to join our team. In this role, you will oversee clinical trials, prepare regulatory documents, and collaborate with AROs/CROs. You will also provide medical and scientific direction to Clinical Operations and...

  • Associate Director Clinical Science

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Associate Director, Clinical ScienceAbout the RoleWe are seeking an experienced Associate Director, Clinical Science to join our team at Daiichi Sankyo, Inc. This is an exciting opportunity to lead clinical development projects and contribute to the creation of innovative pharmaceutical therapies.Key ResponsibilitiesStudy Strategy: Develop and implement...

  • Clinical Director, Oncology Research

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Lead Clinical Development in OncologyDaiichi Sankyo, Inc. is seeking a highly skilled Clinical Director to lead clinical development in oncology. As a key member of our team, you will oversee non-pivotal trials, prepare clinical sections of regulatory documents, and collaborate with AROs/CROs.Key Responsibilities:Develop study strategies and provide input on...

  • Clinical Science Director

    4 weeks ago

    Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job OverviewAs a Clinical Science Director at Daiichi Sankyo, you will oversee one or more trials of medium to high complexity in design and geographic scope. This role requires strategic direction, clinical expertise, and leadership skills to drive the success of our clinical development programs. Key ResponsibilitiesDevelop and implement clinical study...

  • Global Oncology Strategic Planning Director

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryThe Associate Director, Global Business Strategy, will provide strategic insights and direction on the short and long-term potential for the Global DS Pipeline compounds and launched brands. This role will be responsible for the development and maintenance of Short to Long Term Forecasts for the consolidated Global Oncology Portfolio to inform key...

  • Data Science Associate Director

    3 weeks ago

    Basking Ridge, New Jersey, United States Verizon Full time

    **Unlock Business Potential with Data-Driven Insights**At Verizon, we're committed to empowering our customers and driving innovation through data science. As the Associate Director of Applied Analytics, you'll lead a team of experts in finding revenue and retention opportunities within our Consumer base.**Key Responsibilities:**Develop and execute...

  • Medical Director, Oncology

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Medical Director, OncologyDaiichi Sankyo, Inc. is seeking a Medical Director, Oncology to join our Executive Leadership team for the US Oncology Business Division. As a key member of the team, you will contribute to the creation, championing, and execution of the strategic direction and long-term vision for the Company.The successful candidate will lead the...

  • Associate Director, External Sponsored Research

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Legacy of InnovationDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.With more than 120 years of scientific expertise and a presence in over 20 countries, Daiichi...

  • Associate Director, Global Business Strategy

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Global Business StrategyAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving healthcare outcomes through innovative therapies. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing unmet medical needs and improving...

  • Associate Director, Clinical Science

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Study Strategy:Develops and implements clinical study strategies to ensure successful trial execution. Collaborates with Biostats, Data Management, and Data Operations to design and implement data management plans, edit checks, and data quality listings. Reviews patient population and protocol compliance to ensure consistency with study strategy.Study...

  • Associate Director, Global Business Strategy Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Global Business StrategyAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving the lives of patients worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing diversified, unmet medical needs of people...

  • Associate Director, Global Business Strategy Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Global Business StrategyAt Daiichi Sankyo, Inc., we are seeking an experienced Associate Director to join our Global Business Strategy team. As a key member of our team, you will be responsible for providing strategic insights and direction on the short and long-term potential for our Global DS Pipeline compounds and launched...

  • Associate Director, Clinical Science

    3 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Study Strategy:Develops and implements the strategic direction for clinical trials, collaborating with Biostats, Data Management, and Data Operations to ensure EDC, edit checks, data quality listings, SAP, and Data Management plans are aligned with study objectives.Study Planning and Execution:Provides input on major milestones, clinical trial plans, and...

  • Associate Director, External Sponsored Research

    4 weeks ago

    Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director to lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research initiatives. The successful candidate will ensure strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA)...

  • Associate Director Regulatory Writing

    2 months ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryThe Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines.ResponsibilitiesWrite critical, complex clinical and clinical...

  • Associate Director Clinical Safety Scientist Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States The Fountain Group Full time

    {"title": "Clinical Safety Scientist Associate Director", "subtitle": "Join The Fountain Group", "content": "Clinical Safety Scientist Associate DirectorWe are seeking a highly skilled Clinical Safety Scientist Associate Director to join our team at The Fountain Group. As a key member of our safety team, you will be responsible for proactively performing...

  • Associate Director, Companion Diagnostics Lead

    3 weeks ago

    Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.This position will contribute to CDx project teams for the diagnostic, under the direction of the...

  • Associate Director Regulatory Writing

    4 weeks ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job SummaryThe Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines.ResponsibilitiesWrite critical, complex clinical and clinical...

  • Associate Director, Companion Diagnostics Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThe Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.This position will contribute to CDx project teams for the diagnostic, under the direction of the...

Associate Director Clinical Sciences Oncology

2 months ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Details

We are seeking an experienced Associate Director to join our Oncology Clinical Development department. The successful candidate will lead the development, evaluation, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data for a clinical development program. This role will involve leading a matrix environment as part of a cross-functional team and contributing to candidate development projects through early and/or late phase development. The Associate Director will report to the Director, Clinical Sciences and collaborate closely with Medical Directors to provide scientific expertise necessary to design and deliver on clinical studies and programs.

Key Responsibilities:
  • Lead Clinical Scientist for programs and/or delegate of Therapeutic Area Lead Clinical Scientist
  • Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in collaborative activities with other departments
  • Maintain a proficient understanding of therapeutic disease areas and drug candidates, including underlying disease biology, clinical manifestations, and therapeutic standard practice, as well as compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs regarding clinical safety
  • Possess proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; conceive and communicate strategy proposals well-grounded in supporting literature
  • Develop the Expanded Synopsis and author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments
  • Author and/or review documents related to trials, such as medical monitoring plans, SAPs, informed consents, and clinical components of the Clinical Study Reports with minimal guidance and support the development of regulatory documents; perform quality review and may approve, adjudicate, and resolve cross-functional comments with minimal support
  • Lead planning and prepare information for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); present data and information to external investigators (SIV) and internal stakeholders
  • Perform clinical/medical data review, including safety monitoring and activities, and procedures that ensure patient safety
  • Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identify risks and design mitigation strategies
  • Promote consistent first-line medical/clinical data review techniques and conventions across studies/programs; review clinical data review plan and author medical monitoring plan for assigned studies/programs

Requirements:
  • Ability to lead activities within a matrix environment; exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; demonstrated ability to influence within the team and may influence across functionally
  • Demonstrates initiative, creativity, and innovation skills; directly or indirectly contributes to the development of innovations; identifies opportunities for process improvements
  • Resolves novel problems requiring creative application of advanced skill, training, and education
  • May serve as a peer coach, learning how to mentor, and provides guidance to junior members of the department and cross-functional team members as appropriate

Education and Experience:

We are seeking a candidate with a Bachelor's Degree, Advanced degree, or equivalent education/degree in life science/healthcare (PhD/MD/PharmD/MSc) preferred. 10 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. We are seeking proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Strong cross-functional management, interpersonal, and problem-solving skills. Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines.