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Senior/Executive Director, Clinical Operations

Reporting to the Vice President, Clinical Operations, the Senior/Executive Director, Clinical Operations responsibilities will include oversight for clinical study conduct, study planning, budgeting, and financial oversight, vendor/partner management, monitoring study and program timelines, and ensuring compliance with GCP. This position works in a cross-functional environment with representatives from other involved functions. He or she will contribute to, and support, corporate goals to progress the company’s portfolio of products.

Primary Duties and Responsibilities

  • Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met.
  • Oversight of designated activities outsourced to CROs, external consultants, central and specialist labs and other vendors.
  • Participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested.
  • Review required clinical documents.
  • Responsible for the development of, and the oversight for, clinical study milestones to support program objectives.
  • Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation for domestic and international clinical studies.
  • Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards.
  • Provides high level oversight of clinical study data, i.e., flow from the sites (CRF completion) to data entry (data entered into database) to data listings/tables/figures.
  • Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards.
  • Develops work processes or fosters an environment that enhances the cross-functional effectiveness of clinical operations with other functions such as biostatistics, data management, CMC, medical writing, regulatory, finance, and legal, whether these functions are internal or external to Apollomics, Inc.
  • Ensures audit readiness at all times.
  • Ensures adherence to vendor/partner scopes of work, including timelines and budgets, while providing insight and guidance around potential study changes to ensure efficiency and mitigate against fluctuating study costs or study delays.
  • May be responsible for direct supervision or line management.
  • Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals.
  • Perform other duties as assigned by management.

Qualifications

  • Bachelor’s Degree
  • Pharmaceutical, biotechnology, or clinical research experience for a minimum of 15 years, among which, more than 8 years are in Pharmaceutical and Biotechnology industry including demonstrated skills and competency in monitoring and clinical project management tasks.
  • Thorough knowledge of ICH Guidelines, GCP and the clinical trial process.
  • International clinical trial management experience.
  • Insight of study budget process including vendor and Investigator agreements and contracts, CRO budgets, invoicing and payments, site budgets and payment administration.
  • Experience with clinical protocol design, clinical trial operations, clinical trial bio-specimen logistics, and vendor interactions.
  • Demonstrated ability to think strategically and creatively while contributing to multiple projects.
  • Thrives in a highly collaborative, multi-disciplinary team setting.
  • Highly effective verbal and written communication skills.
  • Solid working knowledge of a range of computer packages including Microsoft Office software
  • Ability to manage clinical projects with minimum supervision.
  • Ability to train / supervise and mentor junior staff.

About Apollomics Inc.

Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company’s product pipeline has several programs at different stages of development, including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China.

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