(Sr.) Director, Clinical Operations

1 month ago

Cambridge, United States Proclinical Staffing Full time

(Sr.) Director, Clinical Operations - Permanent - Cambridge, Remote

Proclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study documentation. You will collaborate with various departments to develop high-quality, feasible clinical trial protocols and manage budgets effectively.

This is a remote role with occassional travel.

Primary Responsibilities:

The successful candidate will ensure operational excellence and contribute to study documentation.

Skills & Requirements:

  • Extensive knowledge of clinical trial processes, regulatory requirements, and management systems.
  • Strong leadership and team management skills.
  • Excellent communication, collaboration, and interpersonal skills.
  • Ability to work collaboratively with internal and external stakeholders.
  • Ability to manage multiple priorities with aggressive timelines.
  • Excellent analytical and organizational skills.
  • Working knowledge of project management principles and practices.
  • Strong knowledge of global regulatory requirements, ICH guidelines, and GCP.
  • Proactive problem-solving skills.
  • Creative solutions for issues impacting timelines and budgets.

The (Sr.) Director, Clinical Operations' responsibilities will be:

  • Lead and manage clinical trials from startup to completion.
  • Oversee enrollment, data cleaning, and clinical study report writing.
  • Partner with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, CMC, Project Management, and Regulatory teams.
  • Influence development team thinking for high-quality clinical trial protocols.
  • Contribute to study documentation including protocol, informed consent, clinical monitoring plan, EDC, and statistical analysis plan.
  • Develop and manage clinical trial budgets.
  • Provide regular updates on trial progress to senior management and stakeholders.
  • Identify and mitigate clinical study risks.
  • Facilitate completion of contracts, clinical trial agreements, and budgets.
  • Aid in determining regulatory strategy and preparing submissions to regulatory authorities.
  • Provide direction and leadership in CRO and vendor selection, management, and oversight.
  • Ensure compliance with SOPs, GCP, and ICH guidelines.

If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

  • Proclinical Staffing |

    4 weeks ago

    cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...

  • Proclinical Staffing |

    1 month ago

    cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...

  • Sr. Director Business Development

    3 weeks ago

    Cambridge, United States Clinical Ink Full time

    Founded in 2007, Clinical Ink is an innovation-driven eSource solutions company committed to making clinical research easier for sites, sponsors, subjects and regulators. Guided by a mission to eliminate paper documentation in clinical research, Clinical Ink launched SureSource in 2011 – the company’s flagship product and the industry’s first...

  • Sr. Director of Commercial Operations

    2 months ago

    Cambridge, United States EPM Scientific Full time

    Sr. Director of Commercial Operations & Strategy ExecutionCambridge, MA (Hybrid) - Must be able to be on-site 3 days a weekI am partnering with a large biotech company to find an operational leader who can align the team with its strategic goals and business priorities. This individual will be a key member of the Business Intelligence & Operations leadership...

  • Sr. Director of Commercial Operations

    1 month ago

    Cambridge, United States EPM Scientific Full time

    Sr. Director of Commercial Operations & Strategy ExecutionCambridge, MA (Hybrid) - Must be able to be on-site 3 days a weekI am partnering with a large biotech company to find an operational leader who can align the team with its strategic goals and business priorities. This individual will be a key member of the Business Intelligence & Operations leadership...

  • Sr. Director of Commercial Operations

    2 months ago

    cambridge, United States EPM Scientific Full time

    Sr. Director of Commercial Operations & Strategy ExecutionCambridge, MA (Hybrid) - Must be able to be on-site 3 days a weekI am partnering with a large biotech company to find an operational leader who can align the team with its strategic goals and business priorities. This individual will be a key member of the Business Intelligence & Operations leadership...

  • Sr. Director Business Development

    2 weeks ago

    Cambridge, MA, United States Clinical Ink Full time

    Founded in 2007, Clinical Ink is an innovation-driven eSource solutions company committed to making clinical research easier for sites, sponsors, subjects and regulators. Guided by a mission to eliminate paper documentation in clinical research, Clinical Ink launched SureSource in 2011 – the company’s flagship product and the industry’s first...

  • Director/ Sr. Director, Clinical Operations

    6 days ago

    Cambridge, United States Third Rock Ventures Full time

    A well-funded and highly innovative start up from Third Rock Ventures is emerging out of stealth with a syndicate of marquee investors and is seeking an experienced Clinical Operations leader. Reporting to the SVP of Clinical Development and Operations this person will be responsible for leading clinical operations.Job ResponsibilitiesResponsible for...

  • Clinical Operations Director

    2 weeks ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    Job Description:We are seeking an experienced Clinical Operations Director to lead the management of late-stage clinical trials for our pharmaceutical company. This role will oversee the integration of project team activities, leveraging internal and development partner resources, expertise, and knowledge.About the Role:Provide strategic input and execution...

  • Senior Director of Clinical Operations

    6 days ago

    Cambridge, Massachusetts, United States Sarepta Therapeutics Full time

    Are you a seasoned clinical data management professional looking for a new challenge? Do you have experience in managing external data providers, developing standards and data transfer specifications, and collaborating closely with IT colleagues? If so, we want to hear from you!About the JobAs a Senior Director of Clinical Operations, you will be responsible...

  • Global Clinical Operations Director

    3 weeks ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    Job OverviewWe are seeking a highly skilled Global Clinical Operations Director to lead our clinical development planning and strategy. The successful candidate will be responsible for aspects of clinical study planning and execution within pre-specified timelines and budget.About the RoleLead and manage integration of all project team activities, leveraging...

  • Director/ Sr. Director, Early Pipeline Commercialization

    2 weeks ago

    Cambridge, United States Scholar Rock Full time

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...

  • Third Rock Ventures | Director/ Sr. Director, Clinical Operations

    6 days ago

    cambridge, United States Third Rock Ventures Full time

    A well-funded and highly innovative start up from Third Rock Ventures is emerging out of stealth with a syndicate of marquee investors and is seeking an experienced Clinical Operations leader. Reporting to the SVP of Clinical Development and Operations this person will be responsible for leading clinical operations.Job ResponsibilitiesResponsible for...

  • Sr Director, Analytics

    4 weeks ago

    Cambridge, United States Analytic Recruiting Full time

    Sr Director, Insights & Analytics Leading pharma company is seeking a Sr Director, Insights and Analytics to support the Alzheimer's franchise by defining and evaluating brand performance, enabling data-driven decisions, and proactively delivering actionable insights. Responsibilities include insights and analytics, including primary marketing research,...

  • Sr. Director, Data Engineering

    1 month ago

    Cambridge, United States Capital One Full time

    Center 3 (19075), United States of America, McLean, VirginiaSr. Director, Data EngineeringCapital One is seeking a Sr. Director of Data Engineering to work in our Enterprise Data organization. This individual will specifically be leading teams delivering and expanding highly performant and scalable data products and platforms to drive consumption of data...

  • Sr. CEC Medical Reviewer

    3 weeks ago

    Cambridge, United States Joulé Full time

    Title: Sr. CEC Medical Reviewer Find out more about this role by reading the information below, then apply to be considered. Clinical Events Committee (CEC) Location: Boston MA Local Hybrid Schedule: Monday thru Friday 8-5pm est (over time as needed to meet deadlines) Duration: 12 months contracting Education: MBBS or RN (licensed in MA) or Physician...

  • Senior Clinical Operations Director

    1 week ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    Why Work at Sarepta Therapeutics?Sarepta is a leader in the development of genetic therapies for rare diseases. As a Senior Clinical Operations Director, you will play a key role in accelerating our mission to bring innovative treatments to patients.About the RoleWe are seeking an experienced Senior Clinical Operations Director to lead our feasibility and...

  • Clinical Operations Expert

    1 week ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    About the Role:We are seeking a highly experienced Clinical Operations Expert to join our team as a Sr. Manager, Global Study Start-ups.Job Description:Drive global study start-up and site activation activities, ensuring timely delivery of milestones and CRO performance.Develop and deliver comprehensive global study start-up plans in partnership with the CRO...

  • Senior Clinical Operations Director for Global Drug Development

    1 week ago

    Cambridge, Massachusetts, United States Lifelancer Full time

    Alnylam Pharmaceuticals seeks a highly skilled Senior Clinical Operations Director to lead the delivery of clinical trials in our global drug development team.About AlnylamWe are a leading biopharmaceutical company that has led the translation of RNA interference (RNAi) into innovative medicines with the potential to transform lives. Our culture is guided by...

  • Sr. Director of Strategy

    2 weeks ago

    Cambridge, MA, United States EPM Scientific - Phaidon International Full time

    Sr. Director of Commercial Operations & Strategy Execution Cambridge, MA (Hybrid) - Must be able to be on-site 3 days a week I am partnering with a large biotech company to find an operational leader who can align the team with its strategic goals and business priorities. This individual will be a key member of the Business Intelligence & Operations...