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Clinical Science Liaison

The Clinical Science Liaison (CSL) will serve as a value added resource to sites and investigators and to support the Company’s Clinical Development Programs. The CSL will be responsible for building and managing relationships with, Key Opinion Leaders (KOLs), clinical trial investigators and research staff to ensure full engagement throughout the course of the study. They will also work to build relationships, where appropriate, with patient groups, scientific organizations, and advocacy organizations.

The primary focus for the CSL role will be to enhance clinical trial execution and enrollment through building deep relationships with study investigators and research staff in their region.   The CSL will work with the clinical investigators and site staff to provide education, support enrollment and retention initiatives, identify mitigate and provide solutions to enrollment hurdles, disseminate product/trial information, represent company interests and provide scientific intelligence.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.

Primary Duties and Responsibilities

  • Manage the process for the company’s clinical studies effort to ensure the highest level of success of clinical protocols, investigator brochures, FDA/Health Authority review, and clinical study reports.
  • Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates.
  • In conjunction with clinical development staff, direct and oversee clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board/Ethics Committee applications, training, monitoring, documentation and data analysis.
  • Review and approve procedures for the design and implementation of clinical protocols, data collection systems and final reports.
  • Ensure that all clinical studies are appropriately designed and effectively executed and monitored.
  • Provide safety surveillance guidance, acts as a medical monitor and ensures adherence to cGCP requirements and all applicable regulatory references and guidelines.
  • Manage outside consultants and vendors to ensure data is accurately collected and analyzed in a cost effective fashion.
  • Exhibits leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction).
  • Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies that are efficient in time and money, and hedge risk as needed.
  • Conduct literature reviews and prepare summaries to support clinical development programs.
  • Prepare manuscripts, abstracts and presentations for scientific meetings.

Qualifications

  • PhD/PharmD/MD with Hematology/Oncology experience preferred.
  • A proven leader with at least 5+ years of clinical development experience in the biotechnology or pharmaceutical industry, preferably with management experience.
  • Demonstrated outstanding leadership of multiple development projects and teams and has the ability to work effectively with other clinical and scientific leaders.
  • Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.
  • Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals.
  • Extensive experience leading the design, conduct, analysis, and reporting of clinical studies, including experience submitting NDAs/BLAs to regulatory authorities in the US and Europe.
  • Significant successful interactions with key opinion leaders and investigators.
  • An excellent scientific track record demonstrated by publication record in refereed journals.
  • Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage internal and external partnerships.
  • Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion.
  • Strategic agility; in-depth knowledge and broad experience in the pharmaceutical or biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives.
  • Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions.
  • Strong interpersonal, influencing, presentation, and written and verbal communications skills; able to effectively address all levels within an organization.
  • Willingness and ability to travel.

Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.

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