Senior Director Clinical Programs

3 weeks ago

Gaithersburg, United States eTeam Full time

Title: Senior Director Clinical Programs

Location: Gaithersburg, MD

Duration: 12 Months Contract

Hybrid: 3 days/week onsite


Senior level cross functional experience in study leadership, not only operational level leadership experience.

- A minimum of 5 years of early global oncology study leadership experience.


Description:

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 Clinical Supply Program Lead/Director

    1 week ago

    Gaithersburg, United States AstraZeneca PLC Full time

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies. Pharmaceutical Technology and Development (PT&D), within Operations,...

  • Senior Global Clinical Operations Program Director, Late Development Oncology

    2 days ago

    Gaithersburg, United States AstraZeneca Full time

    Job DescriptionAt AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry,...

  • Senior Director, Clinical Pharmacology

    2 weeks ago

    Gaithersburg, United States AstraZeneca PLC Full time

    Senior Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP) - ADC Introduction to role: Are you ready to make a meaningful impact on patients' lives? We are seeking a Senior Director for our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team within the Biopharmaceuticals R&D division. This role is a unique blend of line management...

  • Senior Director, Clinical Pharmacology

    1 week ago

    Gaithersburg, United States AstraZeneca PLC Full time

    Senior Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP) - ADC Introduction to role: Are you ready to make a meaningful impact on patients' lives? We are seeking a Senior Director for our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team within the Biopharmaceuticals R&D division. This role is a unique blend of line management...

  • Senior Director, Clinical Pharmacology

    1 week ago

    Gaithersburg, United States AstraZeneca Full time

    Senior Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP) - ADC Introduction to role: Are you ready to make a meaningful impact on patients' lives? We are seeking a Senior Director for our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team within the Biopharmaceuticals R&D division. This role is a unique blend of line management...

  • Senior Director, Clinical Pharmacology

    2 days ago

    Gaithersburg, United States AstraZeneca Full time

    Job DescriptionSenior Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP) - ADCIntroduction to role:Are you ready to make a meaningful impact on patients' lives? We are seeking a Senior Director for our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team within the Biopharmaceuticals R&D division. This role is a unique blend of...

  • Director of Nursing ALF

    4 days ago

    Gaithersburg, United States Kisco Senior Living Full time

    Job Description: Lead with passion and compassion as our Director of Nursing ALF at The Carnegie! Direct our top-tier Assisted Living Program, ensuring superior care services are delivered with excellence. Drive resident assessments, medication management, safety protocols, and department budgets as a dynamic and motivating leader. What will I do every day?...

  • Resident Services Director

    4 days ago

    Gaithersburg, United States Kisco Senior Living, LLC Full time

    Job Description Lead with passion and compassion as our Resident Services Director at The Carnegie! Direct our top-tier Assisted Living Program, ensuring superior care services are delivered with excellence. Drive resident assessments, medication management, safety protocols, and department budgets as a dynamic and motivating leader. What will I do every...

  • Director of Nursing ALF

    4 days ago

    Gaithersburg, United States Kisco Senior Living, LLC Full time

    Job Description Lead with passion and compassion as our Director of Nursing ALF at The Carnegie! Direct our top-tier Assisted Living Program, ensuring superior care services are delivered with excellence. Drive resident assessments, medication management, safety protocols, and department budgets as a dynamic and motivating leader. What will I do every...

  • Director, Clinical Operations

    1 week ago

    Gaithersburg, United States Adaptive Phage Therapeutics Full time

    The Director of Clinical Operations will play a pivotal role in guiding the design and implementation of clinical trials sponsored by BiomX. This position entails overseeing several outsourced clinical research programs with a focus on combating bacterial infections, particularly those caused by multi-drug resistant pathogens. The Director of Clinical...

  • Senior Medical Director

    19 hours ago

    Gaithersburg, MD, United States AstraZeneca PLC Full time

    Are you an experienced drug developer with expertise in immunology, rheumatology or inflammatory bowel disease? Would you like to be a part of a talented and high performing team of clinical research professionals, clinical scientists and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies...

  • Group Director Study Operations, Early Oncology Clinical

    2 days ago

    Gaithersburg, United States AstraZeneca Full time

    Job DescriptionAre you excited about Clinical Development and Study Operations? Would you like have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us!!Business areaJoin the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It’s our big vision that unites and...

  • Senior Director, Clinical Pharmacology

    19 hours ago

    Gaithersburg, MD, United States AstraZeneca Full time

    Senior Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP) - ADC Introduction to role: Are you ready to make a meaningful impact on patients' lives? We are seeking a Senior Director for our Clinical Pharmacology & Quantitative Pharmacology (CPQP) team within the Biopharmaceuticals R&D division. This role is a unique blend of line...

  • Senior Medical Director, Early Clinical Development, Oncology

    2 days ago

    Gaithersburg, United States AstraZeneca Full time

    Job DescriptionAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. We have a bold ambition to provide cures for...

  • Director, Evidence Program Management Ii

    1 week ago

    Gaithersburg, United States AstraZeneca Full time

    Join the Medical Evidence Delivery Team within our Oncology Business Unit (OBU) in **Gaithersburg, MD**, and be part of a team that is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca-sponsored studies. Our mission is to generate the evidence that builds confidence in and provides access to...

  • Associate Director, Clinical Pharmacology and

    1 month ago

    Gaithersburg, United States AstraZeneca Full time

    **Associate Director Clinical Pharmacology and Pharmacometrics (Clinical Pharmacology)** Introduction to Role: Are you ready to make a meaningful impact on patients' lives? We are looking for an Associate Director Clinical Pharmacology to join our dedicated Research & Development team in the Biopharmaceuticals R&D department. This scientific role works...

  • Director/Senior Director Biologics CMC Project Leadership

    2 days ago

    Gaithersburg, United States AstraZeneca Full time

    Job DescriptionAre you passionate about science? Do you want to apply your expertise to impact a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We are entrepreneurial, think big and work together to...

  • Associate Director, Clinical Pharmacology and Pharmacometrics

    2 weeks ago

    Gaithersburg, United States WORK180 USA Full time

    Associate Director, Clinical Pharmacology and Pharmacometrics Associate Director Clinical Pharmacology and Pharmacometrics (Clinical Pharmacology) Introduction to Role: Are you ready to make a meaningful impact on patients' lives? We are looking for an Associate Director Clinical Pharmacology to join our dedicated Research & Development team in the...

  • Director, Hollings Manufacturing Extension Partnership Program

    1 month ago

    Gaithersburg, Maryland, United States Department Of Commerce Full time

    Summary The Director, Hollings Manufacturing Extension Partnership Program is primarily responsible for the planning and operation of the Manufacturing Extension Partnership Program (MEP) at NIST, which focuses on modernizing America's manufacturing base through the transfer of modern manufacturing technology and techniques to small and medium-sized...

  • Medical Director, Senior Patient Safety Physician

    2 weeks ago

    Gaithersburg, United States AstraZeneca, plc Full time

    As a Medical Director, Senior Patient Safety Physician in Gaithersburg, UK youll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients lives. Oncology R&D global development drives our innovat Medical Director, Patient, Director, Senior, Medical, Physician