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Clinical Development Lead

2 months ago

Singapore ESCO ASTER PTE. LTD. Full time
Roles & Responsibilities

The Opportunity

Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.


Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.


Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.


Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.


Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.


We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.


The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.


Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.

Esco Aster.


One World Biosolutions for One Health.


The Scope

Esco Aster is looking for a Clinical Development Lead to support our internal and external collaborators encompassing pre-clinical development including CMC (Chemistry, Manufacturing and Controls)/regulatory/GLP toxicology as well as clinical sciences and overseeing clinical operations with external clinical research organizations.


This work involves cross department work within the company as well as part of team that works with external collaborators Chief Medical Officer, Research and Clinical Development teams. This role is for a middle management position, and it will in the midterm involve building a team of direct reports of clinical scientists, clinical research associates, clinical research co-ordinators, clinical ops.


Primary work location: Ayer Rajah Crescent, Singapore.


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, analyses, interpretate scientific/clinical narratives to support clinical, regulatory, and external communication activities.


· Conduct systematic literature reviews, cohesively collates 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.


Requirements

· Minimum MD/PhD or MBBS/MD-PhD degree with relevant publications as a clinician scientist.


· Preferred experience in overseeing as study director for GLP Toxicology.


· Strong technical/ scientific/clinical knowledge on immunology, oncology and/or immunotherapies (CAR-T, TCR-T cell therapies e.g.) 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.


· Have experience the full life cycle of clinical trials from feasibility, selection, initiation and close out activities.


· Ability to conduct and like to read and analyse 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.


Apply now by submitting a Cover Letter and CV to jobs@escoaster.com.


Tell employers what skills you have

CRO
Biomarkers
Medical Writing
Interpersonal Skills
Regulatory Affairs
Immunohistochemistry
Patient Advocacy
Virology
Biology
Trials
Medical Devices
Product Development
Life Sciences
Business Development
GLP