Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Associate Director Clinical Operations

  • Location

    San Diego, California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive - Above Market Average

  • Contact:

    Bobby DeMarco

  • Contact email:

    b.demarco@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    REF - 105

  • Published:

    22 days ago

  • Expiry date:

    2021-12-05

  • Startdate:

    ASAP

Associate Director Clinical Operations

Location: San Diego, California 

Type: Full Time Permanent

Salary: Excellent salary, bonus and accompanying benefits package (Relocation provided). Remote Flexibility.

Exciting opportunity to join a well rounded, novel therapeutics biotech in SoCal to help manage their clinical oncology portfolio. My client is currently in phase 2 with their leading program and this role is designed to assist in the managing of clinical trial sites, as well as vendors and study start up and close out. 

SCOPE:

The Associate Director, Clinical Operations will provide assistance in the implementation of proceses for clinical trial execution. The ideal canddidate will have all aspects of trial execution from study start-up to close-out, including assisting in the management of clinical vendors or CROs and assisting in the oversight of resources, budgets, contracts, and timelines. The right candidate would have worked with small molecule oncology clinical trials.

RESPONSIBILITIES:

  • Assist in the management of key study-related activities and deliverables. 
  • Manage or assist in the management of large global oncology clinical trials (Phase 1-3), 
  • Participate in site and vendor selection and qualification. 
  • Conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO, review trip reports, and implement training as needed to ensure compliance with the protocol and other study-related documents. 
  • Track study progress and maintain study status updates 
  • Review and provide input on study documents 
  • Perform ongoing review of trial TMF(s) to assure quality and compliance with relevant SOPs and ICH-GCP. 

EDUCATION/EXPERIENCE:

  • Bachelors Degree required (Masters, PharmD, or PhD preferred)
  • Min of 4 years of clinical trial management experience
  • Small molecule global clinical trial experience
  • Can be onsite in San Diego or fully remote

SKILLS:

  • At least 2 years of relevant oncology experience in clinical operations in pharmaceutical company or CRO.
  • Clinical trial experience preferred 
  • Demonstrated track record of successfully supporting multiple projects, trials, and priorities. 
  • Experience with managing study vendors

I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (646)-349-4344 or at b.demarco@hamlynwilliams.com

#LI- BD1