Medical Director, JapanLocation Tokyo, Japan Workstyle Open to Hybrid Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Medical Director is a position supporting the scientific and business interests of BioMarin by identifying current and future Thought Leaders (TLs) in academic and clinical medicine at the local, national and regional level and interacting with them.
Medical Director must ultimately possess in depth knowledge of BioMarin’s approved products, agents in clinical development, and all associated disease state areas.
The Medical Director supports the identification, initiation and development of Independent Research Trials (IRTs)and supports BioMarin registries and other clinical programs (these protocols are activated to complement or supplement the overall product development plan). The Medical Director must possess the capacity to coordinate and manage large solo initiatives or partnerships with external partners independently or with a minimum amount of oversight.
This position will report to the Sr. Director, Medical Affairs, APAC, who heads up the Medical Affairs team in the APAC region and will work closely with the Commercial and the Clinical Teams.
- Act as the key local contact for both external and internal customers of the geographical area and will be consistently recognized as an expert on diseases and BioMarin drugs and compounds
- Develop local medical strategy based on Global and Regional medical strategy
- Develop and execute Medical Plans within the region to meet company-defined goals within corporate and regulatory guidelines for products both marketed and in development
- Work closely with Regional and Global Medical colleagues, including Regional Medical Leads
- Oversee the Identification, development, management and interactions with TLs, and the development of long-term peer to peer relationships
- Participate in Advisory Board meetings
- Interact with key investigators to facilitate research on BioMarin products
- Visit potential research sites to determine the site’s ability to conduct and accrue to clinical research studies and registries (ie. patient volume, research experience, methodologies, competing studies, etc).
- Implementation and coordination of extramural research (Investigator Sponsored Trials) intended to support the clinical and scientific strategy for the product.
- Liaise with the clinical department by forwarding potential investigators for other BioMarin products in development
- Maintain clinical and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings and partner with medical, research and commercial teams.
- Provide relevant medical education to HCPs in line with regional medical plans
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources.
- Requests and analyzes literature searches to integrate information into presentations/discussions.
- Builds mutually beneficial long-term relationships with investigators and BMRN to address current and future business needs
- Demonstrate thorough understanding of both clinical and commercial strategies and priorities.
- Deliver high quality scientific presentations on BioMarin products to physicians and other key external customers.
- Provide medical and scientific contributions to internal cross-functional teams and initiatives with internal departments (Medical, Sales, Marketing, Training, etc)
- Support of BioMarin products such as representing BioMarin and BioMarin products at exhibits during scientific symposia. Attendance at local and regional congresses and scientific meetings.
- Identify and recommend speakers for BioMarin’s Speaker’s Bureau and Advisory Boards, in conjunction with other medical team members
- Serve as resource to the commercial team on market intelligence
- Assist in the site level management of the publication plan timelines.
- Provide assistance with the training and mentoring of new BioMarin colleagues.
- Provide clinical education support for internal customers.
- Recommend innovative ideas that impact the Medical Affairs department.
- Proactively provides feedback on emerging clinical/competitive trends.
- Assure compliance with BioMarin operational guidelines.
- Reviews applicability/suitability of promotional materials in the relevant geographic area
- Reviews study-specific processes to address inefficiencies, remove obstacles, and/or revise processes.
- Consistently and independently identifies and implements educational/training programs.
- Continuous training on relevant local laws and regulations.
- Business travel required and may include weekends.
- Medical Doctor (M.D.) degree as well as relevant residency/fellowship experience, Doctor of Pharmacy (Pharm.D.) degree or other relevant Ph D. with experience.
- Experience in a pharmaceutical company is needed.
- 8-10 years in pharma
- Clinical and scientific experience required
- Pharmaceutical experience required, experience with Rare Diseases preferred and experience working with gene therapy products ideal
- Must demonstrate understanding of Good Clinical Practice (GCP) and the ability to develop effective training and protocol materials.
- Strong presentation skills and the ability to present clinical data is required.
- In depth knowledge of the regulatory environment in the geographic area (specifically in regards to orphan drugs; gene therapies)
- Experience in public presentation required and education program development preferred.
- Good business sense and strategic thinking is essential.
- Goal oriented; knows how to set aggressive targets and can identify and re-plan when target performance will not be met.
- The ability to work effectively on multi-disciplinary teams and with both internal and external customers to implement action plans.
- Utilizes effective, professional communications to cultivate strong working relationships with internal and external colleagues
- Proficiency in English
- People management experience
- Great understanding and knowledge on local laws, regulations and business environment related to medical affairs, clinical care and academic research
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.