SVP, Translational Medicine
Harpoon Therapeutics 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. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. 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 small cell lung cancer and other DLL3-associated tumors. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
As The SVP of Translational Medicine and part of our executive management team, you will be responsible for leading and expanding our translational medicine group. This role will serve as the company and external representation for Translational Medicine strategy development and decision making for drug selection, IND submission, and clinical trials.
- Direct leadership for established and growing Translational Medicine function.
- Assemble and participate in cross functional product development teams (PDTs) and lead teams as may be required; provide leadership in advancing Harpoon’s experimental drug molecules from discovery to IND submission and beyond.
- Act as the point of contact and represent IND programs to executive management and the board of directors.
- Work closely with Research, Nonclinical, CMC, Regulatory, and Clinical representatives on PDTs to establish translational medicine-specific goals and strategies for development programs; ensure alignment, timely execution, and achievement of program goals.
- Oversee and participate in authoring regulatory documents for submissions to US and international health authorities.
- Participate in meetings with regulators, i.e. FDA and other as needed.
- Provide direction and strategies in nonclinical studies, biomarker, and diagnostics for experimental drug molecules in clinical trials.
- In collaboration with Research and Clinical groups drive program-specific translational research, e.g., provide scientific rationale for combination clinical trials, strategies for patient selection and/or stratification.
- Develop and execute clinical pharmacology, nonclinical, bioanalytical plans for advanced stage clinical programs.
- Identify academic collaborators, set up and manage collaboration that aligns with corporate direction set for development programs. Act as the main liaison with academic partners to ensure positive and productive interactions.
- Lead a team of scientists and non-scientists including development of both individual staff and overall department structure.
- A PhD in a relevant field of study in cancer biology, tumor immunology, chemistry, or pharmaceutical science, PharmD, MD, or DMV.
- 15+ years of leadership role with increasing responsibilities and a proven track record in the discovery and clinical development of biologics for treatment of cancer or related diseases and in successfully advancing drug candidates from research into clinical development.
- In depth knowledge and hands on experience in directing and managing drug discovery research, clinical biomarker research, diagnostics development, and/or toxicology programs in biotech or pharmaceutical companies.
- Ability to navigate a fast-evolving biotech drug development environment and work across functions to align critical activities in Research/Discovery, Nonclinical, CMC, Regulatory, and Clinical Development to ensure timely program progress.
- Ability to create, lead and foster a collaborative team environment, develop trust, and ensuring transparent communications.
- Negotiate with and influence key stakeholders.
- Effective communication skills in presenting to internal (scientists, PDT members, management, executives, and board of directors) and external (scientific conferences, publications, working groups, and regulatory interactions) audiences.
- Knowledge in regulatory guidance, requirements, and expectations in the US and internationally.