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Clinical Development Lead

2 months ago

Singapore ESCO ASTER PTE. LTD. Full time
Unlock Your Potential as a Clinical Development Lead at ESCO ASTER PTE. LTD.

We are seeking a highly skilled and experienced Clinical Development Lead to join our team at ESCO ASTER PTE. LTD. As a key member of our Clinical Development team, you will play a critical role in the development and implementation of our clinical trials, ensuring that our products meet the highest standards of quality and safety.

Key Responsibilities:
  • Develop and implement clinical trial protocols, ensuring compliance with regulatory requirements and company standards.
  • Collaborate with cross-functional teams, including Medical Affairs, Regulatory, and Clinical Operations, to ensure seamless execution of clinical trials.
  • Provide scientific and technical expertise to support the development of clinical trial materials, including protocols, informed consent forms, and investigator brochures.
  • Ensure compliance with Good Clinical Practices (GCP) and regulatory requirements, including FDA and EU regulations.
  • Develop and maintain relationships with key opinion leaders, clinical investigators, and other stakeholders to ensure successful clinical trial execution.
Requirements:
  • Minimum MD/PhD or MBBS/MD-PhD degree with relevant publications as a clinician scientist.
  • Preferred experience in overseeing GLP Toxicology studies.
  • Strong technical/scientific/clinical knowledge on immunology, oncology, and/or immunotherapies (CAR-T, TCR-T cell therapies, etc.) is highly preferred.
  • Understanding of laboratory techniques in one or more of the following areas: Flow cytometry, serology, toxicology, clinical virology, immunohistochemistry, immunological assays, development of biomarkers to determine efficacy, on target, off target, and enable stricter inclusion criteria.
  • Ability to conduct and like to read and analyze as well as write documents based on database/literature searches with critical analytical thinking and problem-solving skills using PUBMED, EMBASE, MEDLINE, etc.
  • Prior experience in preparing entire clinical dossier and previous track record in receiving IND approval and up to phase 2 Clinical Trial Material.
  • Minimum 5 years of medicine and/or surgical practice.
  • Deep understanding of immunology.
  • Experience and knowledge of clinical research/development, Good Clinical Practices (GCP) and/or regulatory requirements for the conduct of clinical trials preferred.
  • Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
  • Excellent project/process management and communication skills.
  • Able to work well independently and in a team.
  • Possess strong interpersonal skills and ability to collaborate effectively with internal and external stakeholders.