Director of Clinical Outsourcing

Location
New York, NY, USA
Posted
Nov 06, 2020
Ref
202513
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical-stage company focused on the discovery and development of targeted biologic therapeutics. Our proprietary drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases. For more information, please visit MTEM's website at www.mtem.com

Location: New York, NY or remote

Position Overview:

The Director of Clinical Outsourcing (DCO) is responsible for leading and overseeing all cross-functional outsourcing activities for the MTEM Clinical team. The DCO must clearly demonstrate excellent cross-functional collaboration skills and organizational abilities. The DCO will lead the Clinical vendor identification and selection process, including identifying vendor scope specifications for outsourced Clinical activities. The DCO will also work closely with the Director of Financial Planning and Analysis to support the Clinical accruals and forecasting process. The successful candidate will oversee the financial aspects of all Clinical vendors and work to identify and leverage efficiencies across programs. This position reports to the SVP of Clinical Operations. As the need for outsourcing management increases, the DCO will be required to build and manage a team to meet the needs of the business.

Job Responsibilities:
  • Work cross-functionally with Clinical leadership, Finance and Legal to define, solicit, and review vendor contract proposals and budgets, and assist with vendor selection.
  • Develop RFPs for CRO bids, liaise with CROs as needed to ensure questions are answered during the bidding/proposal process, organize bid defense meetings as necessary.
  • Own and drive the drafting, editing and finalization process for MSAs, work orders, change orders and consulting agreements for Clinical vendors as needed.
  • Participate in strategic leadership activities as needed, within the Clinical Department, and serve as a contributing member of compound-level global project teams.
  • Communicate effectively with Clinical senior management as needed to ensure alignment across functions to support Clinical programs and maintain overall study budgets (including invoice review and approval as needed).
  • Initiate, cultivate and maintain strong relationships with vendor counterparts and the study teams they support.
  • Work to continuously improve and streamline Clinical outsourcing processes and procedures.
  • Participate in periodic CRO governance meetings to review budget actuals against forecast and assess key performance indicator metrics pertaining to financial performance of CROs.
  • Collaborate with the Director of Financial Planning and Analysis as needed to assess and report vendor PO accruals, and to forecast expected Clinical vendor budget spend.
  • Mentor and train Clinical team members on processes as applicable, and any other duties as assigned.
  • Evaluate processes and technologies; suggest revisions to increase productivity and efficiency.

Requirements:
  • Bachelor's degree in the scientific, life sciences, computer sciences, or related field, required. Advanced degree is preferred.
  • Minimum of 8 years contracts/outsourcing experience in the pharma/biotech/CRO industry.
  • Clear understanding of Clinical Operations and ability to manage multiple external vendors (or clients) simultaneously.
  • In-depth knowledge of Clinical trial budgeting and industry standards related to CRO costing.
  • Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP.
  • Demonstrated leadership skill set.
  • Excellent organizational skills and attention to detail.
  • Proficient in Microsoft Office applications.
  • Ability to communicate effectively in English.
  • Ability to Travel: 5 %.

Reporting Structure:

This position may have supervisory responsibilities in the future. This position reports to SVP, Clinical Operations.

Molecular Templates Inc https://mtem.isolvedhire.com