Study Management Scientist
Singapore | Full-Time
Contract Type: Permanent
Closing date:
Reference: VN1671
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Who we are
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and well-being.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
Role Summary :
The Study Director represents the single point of study control with the ultimate responsibility for the overall scientific conduct of the study, from the conceptualization to the closure. The study director plans, sets up and manages in vitro/vivo studies in a cross-functional way and by regulatory guidelines; interprets robust data up to highest scientific standards and conducts studies in the context of product acceptance and risk assessment.
Responsibilities :
To participate actively in the conceptualization of studies: training studies, short proof of concept studies, establishment of less complex methods, and standard toxicology studies (Genotox, CytoTox and OECD 28d/90d etc). To deliver timely high quality, well-written study related documents: IACUC application, study plan, study report, and all the amendments adhering to the GLP, NACLAR, AAALAC, and 3Rs guidelines.
Based on the scientific questions and objectives of the study, the Study Director shall develop a detailed, well-written study plan consulting similar already existing documents (e.g. study plans for the training or OECD studies) prior to the study start. Study director shall lead the development of new methods needed for the study, in consultation with a senior study director.
To lead and manage the activities of the study team on a daily basis by providing input to the technical staff and ensuring that work is executed according to study plans and timelines; to coordinate the inputs and implement ad hoc requests for changes by scientific team and the quality assurance team; to regularly report (by preparing high quality presentations) and interpret the data to teams in across different affiliates and draw the overall conclusions from the study in consultation with a senior study director.
To act as a deputy study director by providing necessary support to a study director for the activities mentioned above (the level of support depends on the experience of the incumbent).
To plan and conduct studies using project management tools within the timelines and budget; anticipate variations and provide information about changes on a timely basis; liaise with procurement and coordinate the ordering of supplies (i.e. animal order)
To keep up to date with relevant scientific literature, present and participate in internal Journal Club sessions, and participate (i.e. provide graphs, tables, and data) in the preparation of scientific articles and business cases in collaboration with colleagues from other affiliates.
To participate in the development and maintenance of the quality management system by: keeping the SOP and work instruction library current and drafting new SOPs and WKIs based on company needs or advances in technology
Requirements :
* PhD in life sciences, pharmacology, toxicology or other relevant fields
* Minimum 3 years of work experience with experimental animals (preferably rodents), or equivalent experience in a regulatory/scientific environment
* PC Skills: Excellent knowledge of Microsoft office, familiar with customized computer systems, excellent communication skills * Profound understanding of animal testing principles and GLP guidelines, familiar with project management tools
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and well-being.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
Role Summary :
The Study Director represents the single point of study control with the ultimate responsibility for the overall scientific conduct of the study, from the conceptualization to the closure. The study director plans, sets up and manages in vitro/vivo studies in a cross-functional way and by regulatory guidelines; interprets robust data up to highest scientific standards and conducts studies in the context of product acceptance and risk assessment.
Responsibilities :
To participate actively in the conceptualization of studies: training studies, short proof of concept studies, establishment of less complex methods, and standard toxicology studies (Genotox, CytoTox and OECD 28d/90d etc). To deliver timely high quality, well-written study related documents: IACUC application, study plan, study report, and all the amendments adhering to the GLP, NACLAR, AAALAC, and 3Rs guidelines.
Based on the scientific questions and objectives of the study, the Study Director shall develop a detailed, well-written study plan consulting similar already existing documents (e.g. study plans for the training or OECD studies) prior to the study start. Study director shall lead the development of new methods needed for the study, in consultation with a senior study director.
To lead and manage the activities of the study team on a daily basis by providing input to the technical staff and ensuring that work is executed according to study plans and timelines; to coordinate the inputs and implement ad hoc requests for changes by scientific team and the quality assurance team; to regularly report (by preparing high quality presentations) and interpret the data to teams in across different affiliates and draw the overall conclusions from the study in consultation with a senior study director.
To act as a deputy study director by providing necessary support to a study director for the activities mentioned above (the level of support depends on the experience of the incumbent).
To plan and conduct studies using project management tools within the timelines and budget; anticipate variations and provide information about changes on a timely basis; liaise with procurement and coordinate the ordering of supplies (i.e. animal order)
To keep up to date with relevant scientific literature, present and participate in internal Journal Club sessions, and participate (i.e. provide graphs, tables, and data) in the preparation of scientific articles and business cases in collaboration with colleagues from other affiliates.
To participate in the development and maintenance of the quality management system by: keeping the SOP and work instruction library current and drafting new SOPs and WKIs based on company needs or advances in technology
Requirements :
* PhD in life sciences, pharmacology, toxicology or other relevant fields
* Minimum 3 years of work experience with experimental animals (preferably rodents), or equivalent experience in a regulatory/scientific environment
* PC Skills: Excellent knowledge of Microsoft office, familiar with customized computer systems, excellent communication skills * Profound understanding of animal testing principles and GLP guidelines, familiar with project management tools
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes. As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings.
We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
Singapore
50 Science Park Road
#02-07 The Kendall
Singapore 117406