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(Senior) Director, Clinical Operations
$104k-134k (estimate)
Full Time | Scientific Services 2 Months Ago
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Celsius Therapeutics is Hiring a (Senior) Director, Clinical Operations Near Cambridge, MA

Celsius Therapeutics is a community of scientists, technologists, clinicians and drug hunters leveraging single-cell genomic analysis to develop life-changing medicines. Our common goal is to markedly improve human health by integrating data, experience and insight. Our environment is rigorous, fast-paced and collaborative, bringing together passionate individuals who are making an impact. We inspire creativity and discovery by embracing an open culture that fosters innovation, teamwork and excellence.

JOB SUMMARY

We are looking for a strategic leader in Clinical Operations who will be responsible for setting the foundational clinical operations strategy, execution and management of global clinical programs for the entire organization. This strategic expert will report to and partner with our Chief Medical Officer as the company’s first clinical operations leader in establishing the company’s structure and approach to the execution of clinical trials.

RESPONSIBILITIES

  • Ensure goals and objectives of clinical development programs are met, providing strategic and tactical input in the planning, feasibility and execution of clinical trials and overall clinical development plan
  • Lead all clinical trials for the company across therapeutic areas, including the selection, budget negotiation and oversight of CROs and vendors required to operationalize global clinical trials on-time and within budget
  • Lead global cross-functional teams responsible for executing challenging clinical programs on-time, including subject matter consultants (regulatory, manufacturing, statistics), working in partnership with project management
  • Ensure regulatory and quality compliance requirements for clinical research are met (US CFR, EU CTD, local country requirements and ICH GCP), including the development, training and maintenance on SOPs required to adhere to all relevant regulations
  • Establish and manage all documentation and data reporting procedures and processes related to clinical development programs, including clinical record keeping in preparation for audits and inspections
  • Manage the clinical operations budget to ensure clinical development milestones are met within forecast budget, in partnership with our finance organization and project management team
  • Collaborate with the CMO to manage and grow the clinical operations team as the number and complexity of Celsius clinical trials increases
  • Oversee and/or prepare clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports, plan and execute investigator meetings / DMC meetings as required, and in collaboration with the CMO, lead the planning, preparation and execution of Steering Committee meetings for clinical trials
  • Represent clinical operations to for projects teams and senior leadership, and ensure regular reporting for key executional metrics for all ongoing clinical trials

REQUIREMENTS

  • Bachelor's Degree in health science or related degree required
  • Minimum of 10 years in life sciences including a minimum of 8 years of direct experience focused on clinical operations
  • Demonstrated experience in delivering early clinical development process for global programs with a large number of sites
  • Expertise and working knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
  • Proven CRO/vendor management experience, including selection and oversight of CROs and vendors required for complex clinical studies with a large geographic footprint
  • Experience in multiple therapeutic areas desired, autoimmunity or immune-oncology a plus
  • Demonstrated excellence in leadership and project/program management required
  • Strong ability to identify, synthesize and address problems creatively, including innovative operations approaches to achieving program goals
  • Excellent interpersonal and effective communications skills required
  • Team leadership skills including the ability to manage globally distributed and diverse partners needed
  • Experience in orchestrating successful change management including initiation, strategy development and implementation desired

PHYSICAL DEMANDS / ENVIRONMENTAL FACTORS

  • Travel: Requires approximately 10-20 % travel, including overnight and international travel to sites and partnership locations
  • Celsius requires all employees to be vaccinated for Covid-19 as a condition of employment. 

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$104k-134k (estimate)

POST DATE

01/22/2023

EXPIRATION DATE

03/15/2023

WEBSITE

celsiustx.com

HEADQUARTERS

KENDALL SQUARE, MA

SIZE

50 - 100

FOUNDED

2018

CEO

TARIQ KASSUM

REVENUE

$10M - $50M

INDUSTRY

Contract Research

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