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ARTBIO

Senior Director, Clinical Operations

Cambridge, MA · On-site

$120 - $160/hr

Summary The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. This key role ...

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Senior Director, Clinical Operations

ARTBIO

Cambridge, MA • On-site, Remote

Full-time

Re-posted 13 days ago

Job description

Summary
 
The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. This key role leads the clinical operations team and ensures that the company achieves study goals and objectives while maintaining high-quality clinical data and study integrity. The Senior Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, finance, and translational and discovery research, to drive the successful execution of clinical study plans. 
Main Duties and Responsibilities
  • Establish clear standards and expectations for the accurate, timely execution of clinical trials and the operations teams supporting them.
  • Oversee study operational plans and execution from concept through close out and CSR writing, including site and vendor selection, data management, pharmacovigilance operations, imaging and laboratory assessments, and regulatory activities.
  • Assess and provide input into schedule of activities of study protocols from an operational and feasibility perspective.
  • Review DSUR, study protocols, annual reports, and IB submissions for accuracy and alignment to compound strategy.
  • Lead and execute clinical operations strategies and enrollment plans in close collaboration with internal stakeholders, alliance partners, and Clinical Research Organizations (CROs).
  • Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget at an overall study level.
  • Build out an in-house CRA team for Phase 1 study monitoring.
  • Work with the existing clinical trial managers and clinical scientists to ensure trial delivery and success.
  • Collaborate with the manufacturing and logistics teams for alignment on drug product delivery to clinical studies.
  • Work closely with the CMO to develop the global clinical operations budget with a focus on operational excellence, cost efficiency, and quality.
  • Proactively assess potential risks to clinical studies and propose mitigation plans.
Qualifications & Experience Required
  • Bachelor’s, Master's, or higher qualification in life sciences or nursing.
  • Minimum of 7 years of experience in clinical development, including at least 5 years in clinical operations of Phase 1 or 2 oncology clinical studies, with at least 2 of the years in a clinical trial or project management leadership role.
  • Remote flexibility with up to 25% travel within the United States.
Knowledge, Skills & Abilities Required
  • Cross-functional understanding and technical knowledge of drug development processes and clinical trial methodology. 
  • Thorough knowledge and understanding of Good Clinical Practices, ICH Guidelines, and applicable international regulations and guidelines.
  • Strong project management/organizational skills.
  • Excellent technical experience with MS applications (e.g., MS Project, Word, Excel).
  • Experience with study tools, including CTMS, eTMF, Medidata RAVE, and other EDC systems.
About Us
Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.
 
The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital.
 
Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work. 

EEO Statement
ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Questions and Application Process
If interested, please apply and send your CV to HR@artbio.com. All inquiries are treated confidentially.

ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.