Vice President Clinical Operations
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
Harpoon Therapeutics is seeking a Vice President Clinical Operations who will be responsible for developing and implementing strategies to successfully execute Harpoon’s current and future clinical trials. This leadership position requires a self-directed, dynamic, inspirational leader with a passion for advancing treatment options and outcomes in immunotherapy. The VP must possess collaboration and consensus building skills to ensure the clinical stage projects achieve the objectives within budget and timelines with a strong focus on operational efficiency and execution. The ideal candidate will have strong clinical, leadership and communication skills. In addition, the VP will be a hands-on leader willing to roll-up their sleeves to ensure the highest quality of work output.
- Oversees a global clinical operations team responsible for successful delivery and execution of clinical trials across the company portfolio
- Acts as internal champion, ensuring that clinical programs are properly resourced, managed and executed in accordance with agreed timelines, budgets and department goals in support of corporate objectives
- Flexes easily between taking a high level, strategic view and delving into details as needed in partnership with the clinical operations team
- Drives global clinical operations teams through required and complex cross-functional decision making and internal processes to deliver on clinical trial execution
- Proactively supports the management of CRO partnerships and serves on governance committees as part of oversight of CROs and vendors for the efficient execution of our current clinical program and proactive identification and rapid resolution of any performance issues, acting as a point of contact for executive level escalation
- Drives tight financial management of clinical operations vendors including negotiation of performance driven contracts and budgets/change orders, completion of precise and timely accruals by clinical operations team, and accurate forecasting for company operating plans
- Participates in the review, planning and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and identifying operational problems that may impede the study.
- Contributes to developing and providing input to protocols, annual safety reports, clinical study reports, publications/presentations and regulatory submissions.
- Works collaboratively in a cross functional team environment with functional leaders responsible for Program Management, Clinical Development, Biometrics, Medical Writing, Supply Chain, Medical Affairs, Regulatory Affairs, and Legal/Finance & Accounting
- Provides operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.
- Participates in diligence activities for potential new asset acquisition and supports integration of new assets/development teams into the organization
- Offers oversight on the progress of clinical trials and ensures adherence to the protocol, timelines, and budget. This includes the identification, selection, contracting and management of vendors and reviewing site recruitment, initiation and patient enrollment progress
- Leads initiatives in conjunction with Clinical Operations leadership to build clinical operations department infrastructure and implements best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs
- Provides strategic leadership during health authority inspections; ensure compliance with SOPs, ICH-GCP guidelines, regulatory authority regulations, and patient safety standards
- Serves as a key member of the product team and leadership team, and contributes to the development of product and business strategies to maximize the value of the company’s portfolio
- Mentors and develops development operations personnel
- Able to travel internationally to meet with International team members as needed to build collaboration across the development operations
Bachelors Degree or higher in scientific/healthcare/business field
Progressive experience (15+ years) in executing international, registrational enabling clinical trials including in a pharmaceutical/biotech setting where clinical trials were outsourced to a CRO
Minimum 10 years leadership of a global Clinical Operations team
Minimum 5 years experience in leading complex late stage studies and regulatory inspections,
Minimum 5 years experience developing the conduct of oncology clinical trials is strongly preferred
Experience in developing and coaching clinical operations team in end-to-end management of clinical trial conduct, and in-depth knowledge of the pharmaceutical industry, clinical drug development, and regulatory strategies, preferably with extensive Oncology experience
Ability to anticipate future trends in clinical trial execution, is highly collaborative, and has a broad and deep knowledge and perspective of clinical operations and drug development
Effective, proactive, and open communications, to achieve transparency and clarity of clinical trial goals with team members, executive management, key stakeholders and broader organization
Thorough understanding of drug development from IND to NDA
Strategic and proactive thinking, strong scientific and analytical skills, decisiveness.
Proven success in leading and coordinating cross-functional clinical operations teams.
Proven ability to build strong relationships with CROs/vendors and to manage CROs and vendors throughout entire clinical operations life cycle
Comfortable multi-tasking in a fast-paced global company environment and able to adjust based upon changing priorities and various time zones
Experience developing and coaching direct reports and assessing talent and areas of opportunity
Leads by example, role model for other leaders, demonstrates a firm commitment to company values and culture
Harpoon anticipates that the annual base salary for this position could range from between $280,000.00 - $330,000.00 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Harpoon is a multistate employer and the salary offered will be market competitive. At Harpoon, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.