©2018 by Mana Therapeutics.

email contact: crcruz@manatherapeutics.com

CAREERS

MANA Therapeutics is a clinical stage cell therapy company with pioneering solutions for cancer, bringing powerful cell therapies to bear on cancers with an unmet medical need. Focusing on novel ways of educating our endogenous immune cells, we have devised clinical cell immune therapies that can eliminate cancer cells and are both safer and have greater breadth than existing therapies.  MANA’s initial focus is acute myeloid leukemia post stem cell transplants.

Director/Sr. Director of Clinical Operations

Position Responsibilities include:

 

  • Oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical programs.

  • Develop and implement clinical project plans in accordance with corporate and regulatory objectives

  • Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)

  • Manage clinical trial resources and reforecasting projections, including hiring plans and external budgets

  • Maintain an inspection readiness state throughout the lifecycle of the trial

  • Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget

  • Contribute to global clinical / regulatory submissions

  • Communicate study updates to senior leadership and in open forum presentations

  • Lead development of departmental SOP’s and ensure compliance

  • May require travel

 

Candidate Requirements:

 

  • Bachelor’s in a scientific discipline; advanced degree preferred

  • Minimum 7 years of experience in a biotech/pharmaceutical, principally in oncology drug development and  clinical operations

  • Comfortable in a fast-paced small biotech environment with the ability to adapt to change

  • Experience over-seeing CRO partners as the point of contact and lead project manager

  • Cell therapy experience a bonus

  • Highly organized, outcome oriented, self-motivated performance

  • Hands-on working style with ability to play as individual contributor as needed

  • In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget

  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, strong conflict management and negotiation skills

  • Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice