Luye Pharma Group Ltd., founded in 1994 and listed on the main board of HKSE in 2014 (02186.HK), is a R&D driven specialty pharmaceutical company focusing on developing differentiated and “high barrier to entry” formulations. The company has state-of-the-art production facilities and R&D centers located in China, U.S.A. and Europe, as well as overseas branch offices in Hong Kong, Singapore and Malaysia with approximately 4,000 employees.

Luye Pharma focuses on developing, producing, marketing and selling innovative pharmaceutical products in four of the largest and fastest growing therapeutic areas — oncology, cardiovascular, metabolism and the central nervous system. The company has a portfolio of over 30 products. The business of Luye Pharma covers global main pharmaceutical markets including China, U.S.A., Europe, Australia, Japan, South Korea, and numerous APAC and LATAM countries. Luye Pharma has established a professional R&D system of international standard and reached international level in the area of new drug delivery system technologies such as microspheres, liposome and TDS. Currently, Luye Pharma has multiple innovative preparations and drugs that are undergoing different stages of registry clinical studies in the USA.

With the vision of being one of the most respected global leaders in the healthcare industry, Luye Pharma will keep adhering to the road of innovation and internationalization, and endeavor to become one of the global leading pharmaceutical companies.

ROLE DESCRIPTION:

Reporting to CEO, Luye Pharma International

Job Location: Princeton-based with a flexible work schedule, including weekly in-person office days and domestic travel. Alternate locations may be considered and can be discussed during the interview process with the hiring team.

Job Background and Main Role:

To support the commercial launch for our newly FDA approved medicine in US market, we are seeking for CNS medical affair professionals to join us and build up this exciting commercial infrastructure, as well as preparing the operation and pipeline launches in the future.

Responsible for:

Serve as central hub of clinical and scientific expertise across business units for development of tools to be used in promotional activities by field sales personnel, training of relevant parties, and development of brand strategies.
Operate as a senior level thought-partner on a variety of strategic initiatives, on-going internal and external deliverables, and special projects, working with the leadership team, and other Luye functions and departments.
Establish a cost-efficient structure for a “fit for purpose” Medical Affairs Department utilizing both in-house and external resources. Recruit and implement a “fit for purpose” Medical Affairs Department, including an appropriate number of Medical Sales Liaison.
Developing and managing medical affair activities for an upcoming US product launch.
Oversee compliance from a medical perspective and lead and participate in company’s compliance efforts in the US.
Developing and maintaining extensive interactions with the external medical-scientific community (collaborative research groups, academic consortia, patient advocacy groups etc.) to advance Luye’s work with patients and other critical stakeholders.
Planning and implementing customer strategies aligned with scientific exchange, clinical and medical education, medical information management, and key opinion leader engagement.
Developing a leading-edge perspective of the evolving scientific, clinical research, and medical practice landscapes.
Ensuring medical and scientific accuracy of manuscripts, publications, and abstracts/posters.
Partnering with R&D by providing appropriate input into feasibility assessments, trial design, and medical writing including the near-term pipeline.
Understanding and keeping up to date with relevant therapeutic/clinical literature by attending conferences and meetings.
Provide direction and advice on issues of a medical, ethical and scientific nature to make informed and sound decisions.
Ensure adherence to all compliance guidelines, policies, and procedures.

Qualification Requirements

Experience Requirements:

Minimum of 5-6 years of Medical Affairs experience. At least 15+ years total of pharmaceutical or relevant medical/clinical experience, preferably in the field of CNS and/or mental health disorders.
Experience with US commercial product launches at a pharmaceutical company.
Expertise with US compliance regulations and guidelines.
Experience working with cross functional teams (e.g. regulatory, clinical development and commercial teams).
Proven ability to analyze and interpret clinical trial and published data.
Proven track record of successfully developing and executing medical affairs activities (e.g. evidence generation, scientific communications, external expert engagements, etc.)
Ability to interact with key opinion leaders and plan and execute scientific advisory boards.
Exceptional presentation skills.
Strong verbal and written communication skills.

Therapeutic Experience:

Prefer experience with Schizophrenia and depression, specifically working with psychiatrists and clinical mental health facilities
Other CNS related therapeutic areas

Education Requirements:

Advanced PhD degree in a medical related field or pharmacology. A Medical Doctor degree is a plus.

Traveling Requirement: up to 50%

Luye Pharma USA Ltd.

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Director of Medical Affairs