Careers

Vice President, Development Operations

COMPANY OVERVIEW

Harpoon Therapeutics is a clinical-stage immuno-oncology company focused on the discovery and development of novel, proprietary bispecific T cell engaging biologic drug candidates for the treatment of various cancers. Harpoon’s first three products are in clinical trials across multiple oncology indications, with a fourth product planned to enter development by the end of 2020. Harpoon is led by an experienced management team committed to advancing novel oncology drugs to help cancer patients.

Key Responsibilities:

  • Provide leadership, strategic oversight, and coordination of both the Clinical Operations and Project Management functions to ensure rapid advancement of multiple, early stage oncology products
  • Partner with Project Team Leaders (PTLs), and collaborate with other functional leaders, to develop, gain approval of, and execute project strategy.
  • Partner with the Executive Team on the generation and execution of annual operational/development goals.
  • Support PMs and PTLs in the conduct and documentation of project team meetings and deliverables.
  • Establish and apply performance indicators and metrics to ensure the successful execution of development plans, and of clinical trials to agreed timelines and budgets.
  • Responsible for implementation and execution of the operational clinical studies strategy.
  • At both the project team and functional level, identify and mitigate risks to ensure timely and successful execution.
  • Collaborate with Finance Group to ensure that functional area resources are sufficient to achieve project goals and objectives.
  • Represent clinical operations and project management to provide updates as required to the Executive Team and other internal stakeholders.
  • Ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority.
  • Mentor Project Management and Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development.

Education/Experience: The ideal candidate will require:

  • Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferred.
  • Demonstrated leadership skills including ability to relay vision for department organization, processes, and change to management and staff; strong written, verbal communication and presentation skills.
  • A minimum of 18 years of experience with expertise in the areas of project management and clinical operations development. Other pharma/biotech functional experience will be valued.
  • In-depth understanding and experience across the clinical operations function, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
  • In-depth understanding and experience of the project management function and relevant tools, with a track record of success in coordinating cross-functional teams to define and execute against strategic development plans.
  • Experience with global drug development; experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
  • Therapeutic experience in Oncology is preferred.

Knowledge, Skills and Abilities:

  • Expertise in clinical operations – demonstrated ability to effectively manage projects and people. Proactive problem solving abilities and follow-through skills.
  • Experience in publication and maintenance of project timelines, Gantt charts, agendas, minutes, and reports is required
  • Expertise in Microsoft Office suite, especially MS Project and similar Gantting software is required.
  • PMP certification is preferred.
  • Expertise in vendor management.
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods.