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Clinical Development Lead

2 months ago

Singapore ESCO ASTER PTE. LTD. Full time
About the Role

Esco Aster Pte. Ltd. is a leading contract research development and manufacturing organization, dedicated to enabling scientists to translate their bench work into commercially available products at affordable prices. We are seeking a highly skilled Clinical Development Lead to support our internal and external collaborators in the development of emerging modalities, including cell-based therapies.

Key Responsibilities
  • Scientific Affairs / Writing
    • Support the development of publication and scientific/clinical meeting strategy; prepare essential content and coordinate authorship of publications (abstracts, posters, manuscripts, presentations).
    • Manage, update and maintain company's clinical/scientific materials, reference library of appropriate high impact publications.
    • Generate, analyze, and interpret scientific/clinical narratives to support clinical, regulatory, and external communication activities.
    • Conduct systematic literature reviews, cohesively collate relevant clinical and scientific information to obtain strategic input into clinical program development, including target diseases/patient populations, draft labels, competitive landscape, and market development.
    • Support and help to onboard and maintain relationship with company key opinion leaders (KOLs), clinical investigators, clinician scientists, academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans and enable expanded access and compassionate usage.
  • Regulatory Affairs / Documentation
    • Medical writing: Provide scientific/clinical input into and assist in the development, maintenance and review of clinical documents and specified regulatory submission documents including clinical protocol, investigator brochures, informed consent form, annual IND reports, clinical study reports, manuscripts, and different scientific/clinical presentations and subsequent amendments.
    • Work across various functions to lead and guide as well as technical writing of phase appropriate clinical, CMC and regulatory strategy working with our collaborators CMC/Regulatory, Scientific/Medical Affairs team.
    • Function as in-house resource to compile and provide relevant scientific/clinical information to subject matter experts (SMEs) from other functions (e.g Business Development & Product Development, Scientific and Clinical Trial Manufacturing Teams) to support collaborations and new product development.
    • Review pre-clinical data of medical products, therapeutic products, medical devices and surgical procedures.
    • Develop protocols for transition of products from experimental settings to clinical trials.
    • Write and review documents required for conducting clinical trials such as investigator's brochure, patient consent form, inclusion and exclusion criteria, providing expanded access/compassionate usage and patient advocacy, working with outsourced CRO on risk assessment and management of potential adverse events and ensuring absolute safety of the patients.
  • GLP Studies
    • Act as Study Director Support as well as provide oversight to outsourced partnered CRO or client appointed CRO.
    • Ensure that animal studies and/or in vitro models are representative of PK/PD/Biodistribution studies for first in man trials.
  • Medical Studies/Clinical Trials
    • Conduct medical studies in accordance with ISO 13485 standards using patented microneedles for hair loss / cartilage repair with naïve exosomes. Data generated from medical studies will subsequently be used for FDA 21 CFR 820 and EU MDR filing as a double-blind, randomized clinical trial, with planned sites in Singapore, Bintan, Japan and Australia. The patented saline control microneedles with/without exosomes (from human and animal source) will be benchmarked against Minoxidil and tested with and without LED light (Red/Blue) wavelengths.
    • Future programs include Osteoarthritis/Cartilage Repair for BM-MSCs autologous therapy, Zonal Chondrocytes autologous therapy, Car-T Blood Cancer and associated cancer cell therapies using cells or naïve/engineered exosomes.
    • Coordinate with internal and external clients including applicable regulatory bodies and business partners (CROs).
    • Serve as primary contact/escalation for clinical trials as assigned.
  • Others
    • Perform tasks in accordance with applicable regulations and site safety requirements.
    • Undertake other tasks as assigned.