Clinical Research Director jobs in Arlington, MA

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

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Senior Global Development Scientist Director
  • 10001087 - Director Clinical Research
  • Boston, MA FULL_TIME
  • Job Title: Senior Global Development Scientist Director

    Locations: In Office in one of these locations - Boston Seaport, Warsaw PO, Barcelona SP or Mississauga CA

    As a Senior Global Development Scientist Director (SGDSD) you will independently provide scientific and clinical input to all aspects of late stage product development. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of Respiratory and Immunology products in late stage development. This role ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.

    In this role you will seek input from the appropriate functional experts and will coordinate these activities in support of clinical studies and programs.

    The SGDSD works as a member of a diverse and motivated team of researchers spanning across multiple divisions of Biopharmaceutical Units. The objectives of this role are set by the Global Clinical Program Lead in agreement with Global Clinical Head(s). The role will have a special focus on late stage clinical trials within respiratory & immunology where this role will work in close collaboration with the study team physician with all aspects of scientific input, clinical data quality metrics and safety evaluation.

    The Senior Global Development Scientist Director independently leads many activities and contributes to science stories, regulatory submissions, process improvement and mentoring scientists and physicians.

    Typical Accountabilities

    • Providing scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
    • Expected to effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, Clinical Operations, and Early Development groups.
    • Be involved primarily in Late Phase (Ph2b and Phase 3) clinical programs but will collaborate with clinical colleagues supporting Early Phase programs as well as Medical Affairs colleagues.
    • Provide expert scientific data/analysis into the preparation of regulatory documents and interactions with regulatory authorities.
    • Provide expert scientific analysis and interpretation of data from ongoing studies and from within the literature.
    • Lead development of quality metrics and data review plan for assigned studies.
    • Support and contribute to Medical Monitoring of trials.
    • Lead and participate in activities that ensure quality, consistency and integration of clinical study related results and ensure a robust safety evaluation process within the clinical team.
    • Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.
    • Participate in the preparation of scientific publications and present scientific results and study protocol to multidisciplinary teams and key partners.
    • Develop and review different clinical documents such as protocols, informed consent, investigator’s brochure, study report, briefing books.
    • Provide scientific input to TA standards

    Education, Skills and Experience Required

    • Scientific doctoral level degree (e.g. PhD or PharmD), relevant clinical qualification, or other relevant university degree with extensive experience from Late Phase clinical development within the industry.
    • Ten or more years of relevant pharmaceutical industry experience (multi-country clinical trials).
    • Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results.
    • Demonstrated ability to work collaboratively in a cross-functional setting, particularly with patient safety, vendors, CRAs, site staff and clinical operations.
    • Experience with regulatory submissions, LCM, advisory boards, annual safety updates.
    • Experience with dermatology and/or rheumatologic therapeutic areas preferred.

    Employer of Choice:

    At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and ignite your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society.

    AstraZeneca is committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be! We encourage and consider applications to join our team from all qualified candidates, regardless of their characteristics.

    We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a strong benefits array of offerings.

    When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and high-reaching world.

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

    AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

  • 5 Days Ago

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Site Director
  • DM Clinical Research
  • Brookline, MA FULL_TIME
  • Site DirectorThe Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality ...
  • Just Posted

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Site Director
  • DM Clinical Research
  • Boston, MA FULL_TIME
  • Site DirectorThe Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality ...
  • 1 Month Ago

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Clinical Research Coordinator I
  • DM Clinical Research
  • Boston, MA FULL_TIME
  • Lab TechnicianThe Lab Technician will be responsible for assisting the clinical research staff in conducting clinical research trials.Duties & Responsibilities:Prepares, processes, and ships laborator...
  • 20 Days Ago

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Clinical Research Investigator
  • DM Clinical Research
  • Boston, MA FULL_TIME
  • Clinical Research InvestigatorDepartmentBostonEmployment TypeFull-TimeMinimum ExperienceManager/SupervisorDM Clinical Research, the largest privately-owned research management organization in the Hous...
  • 2 Days Ago

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Clinical Research Coordinator II
  • DM Clinical Research
  • Boston, MA FULL_TIME
  • Clinic Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Reg...
  • 12 Days Ago

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0 Clinical Research Director jobs found in Arlington, MA area

Arlington is a town in Middlesex County, Massachusetts, United States, six miles (10 km) northwest of Boston. The population was 42,844 at the 2010 census. Arlington covers 3,517.5 acres (14 km2), or 5.5 square miles, of which 286.2 acres (1.2 km2) are covered by water. There are 210.52 acres (0.9 km2) of parkland. Elevation ranges from 4 feet (1.2 m) above sea level (along Alewife Brook) to 377 feet (114.9 m) near Park Avenue and Eastern Avenue. Arlington borders on the Mystic Lakes, Mystic River, and Alewife Brook. Within its borders are Spy Pond, the Arlington Reservoir, Mill Brook, and Hil...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$160,558 to $216,749
Arlington, Massachusetts area prices
were up 2.5% from a year ago

Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020