Vice President, Development Operations
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.
- 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.