Director/Senior Director Clinical Operations
Company: Celldex Therapeutics
Location: New Haven
Posted on: June 6, 2021
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.
- 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
- 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
- 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.
- Computer literacy, proficient in computer applications such as
- Excellent communication skills both verbal and written.
- Excellent interpersonal and organizational skills and attention
- 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.
- BS in scientific discipline or equivalent.
- 10+ years experience in clinical trial management
- 5-8 years experience in Biotech/Pharma.
- 5+ years experience leading, developing, and managing a
- Experience/Interest in drug development, operations, and
- 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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