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Project Manager, Biologics and Immunotherapy

Buffalo, NY 14203

Posted: 09/17/2018 Job Category: Clinical: Clinical Operations and Development Job Number: 2086

The Project Manager, Biologics and Immunotherapy will lead global, multi-disciplinary project teams focused on the research, development and commercialization of T-cell receptor-engineered T cells (TCR-T) and metabolic treatment of cancer. This role may work closely with a key strategic partner on projects that are being jointly developed.

Job Responsibilities:
  • Set up, lead and develop projects.
  • Provide regular reports to executive management to track projects.
  • Manage documentation flow of projects.
  • Contributing intellectually to and assuming accountable for appropriate design and implementation of a various preclinical studies to be conducted both internally and externally.
  • Responsible for summarizing and interpreting results of studies with respect to their impact on the development drug candidates.
  • Tracking of expenditure within the projects.
  • Participating, either hands-on or through the management of CRO’ s or collaborators, in the execution of various preclinical studies (e.g., pharmacokinetic studies, efficacy studies, in vitro assays, safety, ADMET, or chemistry-related studies) associated with drug discovery and development.
  • Work collaboratively within highly integrated, multi-functional program teams encompassing development (clinical, manufacturing sciences, pharmacology, clinical supply as well as biology and chemistry research teams).
  • Contribute and write regulatory documents to support preclinical, clinical, and clinical pharmacology submission to various regulatory agencies.
  • Stay abreast of literature, government guidelines, internal guidances related to preclinical development.
  • Identification and due diligence of external assets for potential acquisition and development
  • Identification and presentation of proprietary projects to potential development partners and management of due diligence.
  • Ability to produce and present quality scientific papers at external meetings and for publication.
  • Ability to frame issues, ask the right clarifying questions, and rationalize decisions.
  • Leverages experience/judgment to integrate information from team members/key advisors to make decisions. Builds productive relationships with  team members.
  • Manages integration points with team members to ensure alignment. Effectively interfaces with functional areas to ensure strategic alignment and to obtain appropriate operational resources to deliver on goals. Ensures appropriate decisions are made in a timely manner at the appropriate levels to drive deliverables.

Required Education & Qualifications:
  • Advanced degree (PhD) in Immunology preferred. Other disciplines that will be considered are Cell Biology, Oncology, Pharmaceutical Sciences, or closely related fields.
  • 5+ years’ relevant industry experience in a biopharmaceutical setting with extensive experience leading drug discovery teams.
  • Knowledge of the structure/function of tumor targeting receptors such as T cell receptors (TCR).
  • Experience in building partnerships and leveraging relationships with internal scientific teams to drive execution of research strategies.
  • Experience with or exposure to the composition and filing of Investigational New Drug Applications.
  • An understanding of all functional areas of drug development, including; chemistry biology, toxicology, clinical development, diagnostic development, etc.
  • Manages and prioritizes multiple projects, provides solutions to complex problems and delivers complete and accurate information within deadlines.
  • Ability to work effectively in a highly collaborative, multi-disciplinary team setting.
  • Accomplishes goals under project time lines.
  • Excellent written and verbal communication skills.
  • Experience using Microsoft Project as a project planning and tracking tool to successfully manage projects.

Julie Monti
Senior Recruiter

Julie brings nearly 20 years of experience to her role as Senior Recruiter for The Steely Group. Throughout her career, she has built lasting relationships and strong partnerships while helping companies build successful teams. Julie is known for her sharp wit, easy smile, sense of humor and genuine interest in people.
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