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Director/Senior Director Clinical Operations

Company: Celldex Therapeutics
Location: New Haven
Posted on: June 6, 2021

Job Description:

Overview

Lead a team of dedicated Clinical Operations professionals who oversee the strategy for implementation and the execution of all clinical trials within the Celldex development portfolio within established timelines, budget and quality standards. As Head of Clinical Operations, the individual will also ensure that the appropriate infrastructure and quality systems are in place to support clinical trial execution. This role reports to the Chief Product Development Officer. Opportunity for remote however regular onsite meetings required at New Haven site as well as other travel to meet business needs.

Responsibilities

  • Leads, expands, and directs the clinical operations team responsible for management and execution of all clinical trials in accordance with regulatory standards, guidelines and Standard Operating Procedures (SOPs). This includes hiring, training, staff development, coaching, mentoring and performance management.
  • Coordinates all Clinical Operations activities, including planning and implementation of all activities required to conduct and monitor complex clinical trials while ensuring cost, quality and timeliness of multiple programs are met.
  • Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
  • Provides strategic and technical guidance to ensure that clinical trials are properly defined, planned, and executed. Continually assesses impact of new and evolving information on operational strategies.
  • Builds collaborative relationships with key stakeholders to support clinical programs. Partners with other functional areas to proactively identify and mitigate issues or delays that could impact timely clinical study completion.
  • Provides strategic oversight of clinical trial budget planning, forecasting and management.
  • Drives the creation of clinical operations SOPs, systems, and processes to ensure efficient day to day operations that meet clinical trial needs; ensures compliance with regulatory and other applicable standards and guidelines.
  • Oversees selection and management of external vendors, including Contract Research Organizations, to ensure compliance with the protocol, applicable governmental regulations, program guidelines and budget.

Qualifications

  • Computer literacy, proficient in computer applications such as MS Office.
  • Excellent communication skills both verbal and written.
  • Excellent interpersonal and organizational skills and attention to details.
  • Ability to motivate staff and drive high quality execution
  • Proven ability to build strong relationships with external partners, CROs, and vendors.
  • Ability to work independently and collaboratively in a fast paced, matrixed, team environment consisting of internal and external team members.

Education/Experience:

  • BS in scientific discipline or equivalent.
  • 10+ years experience in clinical trial management functions.
  • 5-8 years experience in Biotech/Pharma.
  • 5+ years experience leading, developing, and managing a team.
  • Experience/Interest in drug development, operations, and strategic planning.
  • Experience with submissions from Investigational New Drug (IND) filings and Biological License Applications (BLA's) and managing a product from pre-clinical through all clinical phases and product launch is desirable.
  • Experience in Oncology or Allergic diseases preferred

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

Keywords: Celldex Therapeutics, New Haven , Director/Senior Director Clinical Operations, Other , New Haven, Connecticut

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