VP / ED, Head of Clinical Operations (20+ person team) | Remote Based | Late-Stage Biotech: RETAINED SEARCH

Cornerstone Search Group
Published
September 8, 2022
Location
REMOTE, United States, United States of America
Category
Job Code
csaHeadClinOps3141
Contact Email
cackerman@cornerstonesg.com

Description

VP / ED, Head of Clinical Operations (20+ person team) | Remote Based | Late-Stage Biotech: RETAINED SEARCH

Cornerstone Search Group has been retained by a well-funded, late-stage biotech helmed by a highly experienced CEO and management team with a track record of success. This company’s lead asset is a novel treatment with blockbuster potential that addresses serious unmet needs in multiple indications. Our client is seeking an experienced late-stage clinical operations leader with global pivotal trial leadership experience to lead a 20+ person clin ops department and work closely with their high-performing leadership team. This home-based position is for a company based on the East Coast of the United States. This position reports to an MD we know quite well as we introduced him to this Company – he has top-notch credentials, extensive relevant industry experience in leadership roles, and is a real “people person”.

LOCATION: Our client is open to candidates being remotely based.

SCOPE: The Head of Clinical Operations will ensure that the goals and objectives for the Company’s drug development programs are met by providing strategic and tactical input into operational execution of clinical trials. The Head will be responsible for leading all aspects of clinical trial management and oversight at the Company, with responsibility for the planning, execution, quality and GCP compliance of the Company’s clinical trials.

RESPONSIBILITIES IN A NUTSHELL:

  • Manage an in-house team of 20+ as well as oversight of CROs and other vendors. Provide sound leadership to ensure an effective and cohesive team by focusing on team and individual performance, mentorship, coaching, and career development activities. Establish the departmental goals in support of the Company’s corporate objectives and ensure that your direct and indirect reports each have aligned goals
  • Be responsible and accountable for managing the clinical operations and study budgets, including budget preparation, forecasting, tracking and variance reporting.
  • Lead the operational oversight of company-sponsored clinical trials ensuring that they are completed on time and within the approved budget
  • Participate in the preparation of clinical study documents, including Protocols and Amendments, Study Reference Manuals, CRF design, ICFs, CSRs, and IBs.
  • Assist in preparing clinical module documents for IND, NDA, and MAA submissions.
  • Participate in the selection, review, and approval of clinical sites and investigators.
  • Plan and lead Investigator Meetings.
  • Working with the CMC team and applicable vendors, work to forecast investigational product supply needs and oversee the supply chain with the CMC team.
  • Conduct regular resource planning reviews to ensure that clinical development projects are adequately resourced in time and that the team is properly staffed to support clinical development programs
  • Lead regular cross-functional team meetings.
  • Interact regularly with executive management including presenting to BoD.
  • Work with the Medical Monitors, Regulatory Affairs, and the Drug Safety and Pharmacovigilance (DSPV) vendor to ensure that the Company’s drug safety and pharmacovigilance obligations are in compliance with US and global regulatory authority safety reporting obligations.
  • Ensure that clinical trials are conducted and monitored in accordance with GCP/ICH guidelines and Company SOPs. Work with the GCP vendor on the development of new, and periodic revisions of existing, clinical SOPs.

DESIRED SKILLS / QUALIFICATIONS / EXPERIENCE:

  • BA/BS or higher
  • 12+ years of experience in pharma/biotech/CRO
  • US pivotal trial experience is required. EU / Canada experience is a plus.
  • Prior NDA/BLA/MAA submission experience is a plus.
  • Experience with pre-approval FDA or EMA inspections would be a plus.
  • Prior people management experience as you will be leading a 20+ person team of Project Managers, In-House CRAs, and Field-based CRAs. Demonstrated history of performance managing, mentoring, and building teams.
  • Prior experience leading a Clin Ops department or leading a Clinical Ops therapeutic area, or leading a major global clinical program through a global pivotal trial is ideal
  • Experience with complex therapeutics (such as respiratory drug/device, acute care, anti-infectives, rare disease) is a plus
  • Experience developing SOPs and clin ops metrics is desired
  • A varied background with time spent in Clinical Research, Regulatory, Quality, etc. would be a plus but is not required
  • Desire and ability to work in a fast-paced environment with more visibility than in “Big Pharma”
  • Seeking a self-driven, highly organized, detail-oriented, self-aware, accountable, collaborative, independent, high-EQ individual
  • Demonstrated experience of making a meaningful impact (i.e., “but for” your efforts, the same successful result may not have been achieved)

CONTACT:

Corey Ackerman, JD | Senior Partner (a member of Cornerstone since 2001)

E: cackerman@cornerstonesg.com | P: 973.656.0220 x 716

LinkedIn: www.linkedin.com/in/coreyackerman

CORNERSTONE SEARCH GROUP – Life Sciences Executive Search

350 Main Street | Chatham, New Jersey 07928 USA

www.cornerstonesg.com | 973.656.0220

Cornerstone’s Privacy Policy: Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission.

Apply
Drop files here browse files ...
PDF and .doc resume uploads are preferred. docx files are not supported.
Captcha