Senior Director Clinical Programs

4 weeks ago

Waltham, United States Zenith LifeScience Full time

Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents

With oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions

Leads the delivery of the clinical study program(s) or study(s) from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standards

Accountable for overall study or program deliverables, maintaining oversight by close interaction with individual study leaders or leadership of the study team as appropriate

Implement agreed study level process and technology for Early Oncology clinical studies

Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate

Responsible for planning and leading issue escalation and resolution

Provide input to forecasting and management of study delivery costs, resource and timelines

Accountable for the quality of study planning information into relevant planning systems (e.g.: IMPACT, PLANIT)

Guide the study team in the development of outsourcing specifications and vendor selection

Provision to procurement clear specifications for study or program specific outsourcing

Review and operational approval of study or program specific contracts or work orders

Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs

Communicate study level reports and status updates for Early Oncology clinical studies

Lead and conduct investigator meetings and other study related meetings

Identify and communicate resource gaps for assigned studies

Lead risk management and quality efforts to ensure study compliance and continual inspection readiness

Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance

Mentors and supports development of individuals within the organization

Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators

  • Senior Medical Director

    3 weeks ago

    Waltham, United States Clinical Dynamix Full time

    Responsibilities:Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.Drives clinical strategy and leads...

  • Senior Clinical Trials Manager

    2 weeks ago

    Waltham, United States Clinical Dynamix, Inc. Full time

    Global Publicly Traded Pharmaceutical company is expanding.The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs....

  • Senior Medical Director

    2 weeks ago

    Waltham, United States Clinical Dynamix, Inc. Full time

    Responsibilities:Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.Drives clinical strategy and leads...

  • Senior Director, Clinical Regulatory Affairs

    2 weeks ago

    Waltham, United States Dragonfly Therapeutics, Inc. Full time

    Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...

  • Senior Director, Clinical Regulatory Affairs

    2 weeks ago

    Waltham, United States Dragonfly Therapeutics Full time

    Senior Director, Regulatory Affairs Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization. The primary responsibility of this role is to develop regulatory strategies for both non-clinical and clinical aspects,...

  • Director/Senior Director, Clinical Research Scientist

    2 weeks ago

    Waltham, United States Dragonfly Therapeutics Full time

    Director/Senior Director, Clinical Research Scientist Dragonfly Therapeutics seeks a Clinical Research Scientistwith a strong scientific background in Oncology, Immunology, or Immuno-oncology. This position will report to the VP of Clinical Development and be responsible for the implementation, planning, and execution of assigned clinical trial activities....

  • Senior Director, Clinical Pharmacology

    1 day ago

    Waltham, United States Dyne Therapeutics Full time

    Role Summary:The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics. This person will be the company’s subject matter expert (SME)and will be...

  • Senior Director, Clinical Pharmacology

    6 days ago

    Waltham, United States Dyne Therapeutics Full time

    Role Summary:The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics. This person will be the company’s subject matter expert (SME)and will be...

  • Senior Director, Clinical Pharmacology

    6 days ago

    Waltham, United States Dyne Therapeutics Full time

    Role Summary:The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics. This person will be the company’s subject matter expert (SME)and will be...

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Senior Director, Clinical Pharmacology

    2 weeks ago

    Waltham, United States BioSpace Full time

    Job DetailsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • Director of Health and Infection Prevention Control

    2 weeks ago

    Waltham, United States Benchmark Senior Living Full time

    Job Description Joining the Benchmark Senior Living team means putting your passion to work. We invite you to connect with your calling, find purpose in your career, and gain lifelong relationships through the power of human connection by transforming the lives of seniors! The Director of Health and Infection Prevention Control partners with Resident Care,...

  • Director of Health and Infection Prevention Control

    1 week ago

    Waltham, United States Benchmark Senior Living Full time

    Joining the Benchmark Senior Living team means putting your passion to work. We invite you to connect with your calling, find purpose in your career, and gain lifelong relationships through the power of human connection by transforming the lives of seniors! The Director of Health and Infection Prevention Control partners with Resident Care, Quality, Risk...

  • Director of Health and Infection Prevention Control

    3 weeks ago

    Waltham, United States Benchmark Senior Living Full time

    Joining the Benchmark Senior Living team means putting your passion to work. We invite you to connect with your calling, find purpose in your career, and gain lifelong relationships through the power of human connection by transforming the lives of seniors! The Director of Health and Infection Prevention Control partners with Resident Care, Quality, Risk...

  • Director, Clinical Operations

    6 days ago

    Waltham, United States Ophthalmic Consultants of Boston Full time

    Job DescriptionJob DescriptionOphthalmic Consultants of Boston (OCB) is recruiting for a Director, Clinical Operations.  This multifaceted opportunity is 100% onsite.Summary of Responsibilities:The Director, Clinical Operations (Director) has overall responsibility for clinical management of all OCB practice locations.  This includes development and...

  • Director, Clinical Operations

    4 weeks ago

    Waltham, United States Ophthalmic Consultants of Boston Full time

    Job DescriptionJob DescriptionOphthalmic Consultants of Boston (OCB) is recruiting for a Director, Clinical Operations.  This multifaceted opportunity is 100% onsite.Summary of Responsibilities:The Director, Clinical Operations (Director) has overall responsibility for clinical management of all OCB practice locations.  This includes development and...

  • Senior Director, Translational Biomarkers

    4 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Senior Director, Translational Biomarkers

    2 weeks ago

    Waltham, United States BioSpace Full time

    Job DetailsCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • Senior Director, Translational Biomarkers

    3 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Senior Director, FP

    4 weeks ago

    Waltham, Massachusetts, United States Ventus Therapeutics Full time

    Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines...