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Clinical Development Lead

2 weeks ago

Ayer Raja New Town, Singapore Esco Aster Full time $80,000 - $120,000 per year

**The Opportunity**
**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.
**Who we're looking for**
**Physical/Mental Requirements/Work Environment**
- Ability to read, analyze and interpret scientific data and publications
- Ability to author or review protocols, technical reports and technology transfer documents.
- Ability to author or review standard operating procedures and other related documents.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to focus
- Repetitive motions due to certain laboratory techniques
**Report To**:
**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.
- Conducts 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.
- Review pre-clinical data of medical products, therapeutic products, medical devices and surgical procedures.
- Develop protocols for transition of products from experim