Responsibility
1. Responsible for establishing and managing in vitro bioassays of drug discovery projects, including but not limited to literature research, assay method & plan proposal.
2. Responsible for establishment of emerging new technical platforms.
3. Responsible for managing CRO companies of biology related projects, including selecting high quality CRO, timely communication to ensure the expectation for collaboration are met.
4. Team management and training junior scientists.
Requirements
1.Ph.D in immunology, biochemistry, cell biology and related majors with >4 year experience on bioassays in industry, biotech or CROs;
Capable of independent discovery research, and capable of leading a team.
2.A good learner for new drug discovery field and emerging new techs.
3.Intensive in vitro biochemical and cellular bioassay experience;
4.Familiar with common bioassay methods like ELISA, TR-FRET, ALPHA, FP, FACS, In-cell western etc.
5.Experience on ocular drug discovery will be a plus ; Experience on high-throughput screening is a plus;
6.Fluent oral and written communications skills in English;
7.Strong sense of responsibility. Good communication skills and team-oriented.
Serve as Sr. Clinical Project Manager for international projects Phase I, II, III, IV for Bio Pharmaceutical & Medical Device projects, according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP with total responsibility.
Responsible for the successful conduct of assigned projects.
Serve as Project Manager for assigned business development opportunities.
Liaise with senior management in the Delivery and Service Centers to ensure adequate resources are available for assigned projects.
Responsible for on time, on-budget provision of client deliverables for assigned projects.
Education / Qualifications:
Required:
University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Detailed knowledge of financial control procedures
Thorough knowledge of project management processes.
Thorough knowledge of time and cost estimate development.
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Excellent English and also preferably knowledge of some mid level Spanish or Portuguese language with superb grammar skills both written and verbal.
Broad knowledge of drug development process and client needs.
Preferred:
Masters or other advanced degree.
Detailed knowledge of ESTERN Medical and the overall structure of the organization.
Basic knowledge of ESTERN Medical sales and business development strategies and procedures.
Thorough knowledge of ESTERN Medical S.O.P.s
Experience Required:Minimum of seven (7) years relevant clinical research experience in a pharmaceutical / medical device company/CRO, including at least four (4) years of full project management responsibility.
In lieu of the above requirement, candidates with > five (5) years supervisory experience in a heath care setting and > five (5) years clinical research expe
Apply nowReporting directly to the VP of Ophthalmology and based in Shanghai.
Function as medical expert on one or more VivaVision clinical development programs.
Job Responsibilities
Lead the development and implementation of a clinical research plan
Provide medical and scientific expertise into clinical development and protocol planning activities
Serve as expert medical and scientific point of contact for regulatory and ethics committee interactions
Plan and participate in data analyses and creation of key study-related outputs such as clinical study reports and publications
Lead the development and implementation of a clinical research plan
Identify and propose projects to senior management for approval
Assist VP of Ophthalmology Research in prioritizing and allocating resources
Leverage external research collaborators as needed
Investigate, create, and/or develop new methods and technologies for project advancement
Assist in securing intellectual property, including detailed descriptions for patent filing and/or proof of concept work, as appropriate
Minimum Qualifications
PhD in a relevant scientific discipline with 5 years’ industry experience
Expert knowledge of scientific principles and concepts
Significant knowledge of ophthalmic disorders
Excellent oral and written communication skills
Ability to work in a team-oriented environment but also be a self-starter, internally motivated, with the ability to work independently to drive the research forward
Scientifically rigorous, highly organized, with significant attention to detail
Preferred Qualifications
PhD + Post-doc & MD in a relevant scientific discipline and 5 years with industry experience
Knowledge of the pathophysiology and treatment of ophthalmic disorders and related
Prior success discovering and developing successful novel medicines
Proven track record of leading research programs and establishing strong collaborations
High energy level, focus, a passion and sense of urgency for developing important new medicines for devastating diseases
Apply now