This position may be filled at Director/Senior Director/ or Executive Director level. This position will have responsibilities associated with all aspects of design, setup, monitoring, and analysis of Phase 1-3 clinical trials. This person must have excellent analytical and communication skills, and the ability to interact effectively with other members of the team, as well as with study investigators and their staff, CROs and vendors operating on behalf of Apollomics.
Primary Duties and Responsibilities
- Manage the process, and in specific cases act as medical monitor, for the company’s clinical studies effort to ensure the highest level of success, scientific integrity/accuracy and ethical conduct 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).
- Conduct literature reviews and prepare summaries to support clinical development programs
- Prepare manuscripts, abstracts and presentations for scientific meetings.
- M.D. is a requirement.
- Prefer 5+, but at least 3+ years of clinical development experience in the biotechnology or pharmaceutical industry.
- Has the ability to work effectively with other clinical and scientific leaders.
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals.
- Experience leading or playing a substantial role in the design, conduct, analysis, and reporting of clinical studies, including experience submitting NDAs/BLAs to regulatory authorities in the US and Europe, a plus.
- 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.