Assoc. Director/Director, Translational Medicine

Location
94080, South San Francisco
Posted
Jun 18, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Harpoon Therapeutics is an early-stage biotech company located in South San Francisco. The Company is developing biologics with novel molecular formats to engage and activate immune cells for the treatment of cancer and other diseases. With multiple programs positioned to enter clinical development in the next two years, we are evolving into a clinical stage company. We are seeking an experienced candidate with an established track record in advancing drug candidates through nonclinical studies, IND submission, and early phase clinical development. The successful candidate will assume the role of product development team leader in multiple programs and play an essential role in expanding the company’s clinical pipeline.

Responsibilities

  • Lead cross-functional product development teams (PDTs) to advance Harpoon’s experimental drug molecules toward and through clinical development.
  • Work closely with Nonclinical, CMC, Regulatory, and Clinical representatives on PDTs to establish consensus in program-specific development plans; ensure alignment, timely execution, and achievement of development program goals.
  • Provide directions and strategies in nonclinical studies and biomarker research in clinical trials; integrate and communicate project data from Research and Nonclinical Science efforts and articulate their impact to PDT activities.
  • Act as the point of contact and program representative to executive management and board of directors.
  • Author documents for regulatory submissions in the US and internationally.
  • Create a collaborative team environment, develop trust and ensure transparent communications, negotiate with and influence key stakeholders.
  • Act as the main liaison with Harpoon’s academic partners to ensure positive and productive collaboration that aligns with corporate direction in development programs.

Qualifications

  • A PhD, PharmD, or DVM in a relevant field of study in biology, chemistry, or pharmaceutical science.
  • 8+ years of demonstrated leadership experience and track record in directing drug discovery research, drug development, clinical biomarker programs, or toxicology programs in biotech or pharmaceutical companies; experience in developing biologics for the treatment of cancer or related diseases and in successfully advancing drug candidates from research into clinical development is a major plus.
  • Ability to navigate a fast-evolving biotech/pharmaceutical drug development environment and work across functions to align critical activities in research/discovery, nonclinical, CMC, and clinical development to ensure timely program progress.
  • 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.