The Director, Medical Affairs provides medical consultative and interpretive support to Covance Central Laboratory Services and its internal and external customers. The incumbent is responsible for medical decision-making and consultation that relate to laboratory services and clinical trials. Additional responsibilities include consulting with Quality Assurance, Safety Committee, Investigator Site Support, Project Management, Sponsors, and Investigators.
Particularly, this position works closely with clients to support development of new compound in their pipeline. Leads developing/identifying new strategies, techniques and instrumentation for the development of new ventures in the scientific area of expertise for CLS Japan.
Laboratory Operations support:
- Provide medical/pathology/clinical laboratory support to Laboratory operations departments and Investigators sites as needed.
- Collaborate with Laboratory Operations Management for resource planning and utilization for resource allocation to cater the work arising from commercial efforts in Japan market
- Serve as point of contact for regional laboratory operations head, global directors and liaise with support functions such as Sourcing, logistics, etc. for better readiness and feasibility of Japan projects
- Build a Pathology Team to support incoming growth in Japan
Regulatory and Compliance:
- As needed or requested, participate in investigator meetings or client visits to provide medical and laboratory support required for the success of a pharmaceutical drug clinical trial and submission of laboratory data to the FDA.
- Consult with Quality Assurance to ensure compliance with applicable local and international regulations governing clinical reference laboratories, transport of clinical specimens, and pharmaceutical drug clinical trials.
- Assist in interfacing with Sponsors and/or Regulatory authorities as needed.
- Review, approve and implement SOPs
- Serve as site CAP Certificate Holder and maintain CAP laboratory accreditation requirements
- Collaborate with others in the organization in the creation and approval of reference ranges and appropriate test/method selection for a given clinical indication.
- Advise in the development and approval of the technical database, the proprietary clinical trials database, and laboratory information systems.
- Participate in the review and/or approval of new test or service feasibilities.
- Pursue continuing medical education in order to remain current in technology advances in the areas of laboratory medicine and clinical trials.
Business development and support:
- Provide subject matter and drug development expertise and act as a key contributor to the medical strategy and execution of the program for the client
- As needed, interact with Sponsors and Scientific Affairs group in protocol review and/or development
- Perform literature review related to the therapeutic area involved in Sponsor clinical development
- Communicate with clients and clients’ Project Managers to promote project schedule adherence within laboratory operations and meet high quality standards.
- Participate in business development visits to current and potential clients as required.
- Make presentations and represent the company at professional meetings and with prospective and existing clients as required
- Collaborate with business development in review, writing, presentation and defense proposals
- Responsible for supporting the translation of sponsor documents such as synopsis, protocol, etc. from Japanese to English when required for better understanding of sponsor requirements
- Work with the local and Asia Pacific regional commercial teams to actively prospect and leverage potential new business opportunities within new and/or existing Customers/Accounts.
- Analyze potential opportunities and support the development of sales strategies for each customer account. Ensure appropriate scientific/medical strategy/solution is proposed to customer. Monitor actions and results against plans.
- Facilitate and drive necessary technical and scientific decisions and recommendations to enable success of clients’ projects.
- Maintain a growing knowledge bank of information related to sponsor requests, sponsor feedback, key communications, regulatory updates, etc.
- Explore trends in delivery and performance to clients in Japan and assist with developing solutions that cater to the specific needs
- Suggest new products and services based upon customer insight and lead feasibility assessments, ROI, etc. for new capabilities in CLS Japan
- Be a key point of contact for commercial team for NTF/NSSO-type requests
- Be an internal champion for Japan based customers and solutions
- Maintain high visibility within customer organizations
- Upon client request, visit site investigator for face to face explanation session as needed
- MD, Pathologist
- Board certification in scientific area of expertise if needed.
- MD degree in a biologically or medically related field and a minimum 5 years of work experience in Laboratory, Pharmaceutical or CRO setting. Additional relevant experience may be substituted for education requirements above.
- Outstanding program management and organizational skills.
- Experience in working in a client facing role highly desirable.
- Keen knowledge of the challenges linked to drug discovery or diagnostic/biomarker in general and specifically in the Japan market.
- Excellent communication skills across a range of stakeholders, including academic researchers, regulators, industry partners and physicians.
- Ability to work across multiple projects and manage multiple tasks.
- Experience performing scientific presentations and preparing scientific publications.
- Effective communication skills with technical staff, business development staff, peers and clients.
- Fluent in Japanese and English
- Computer literate.