Therapeutic Area Lead (Rare Diseases)Apply Now Email Me Job ID R0009293 Date posted 06/04/2019 Location: Seoul, South Korea
Therapeutic Area Lead (Rare Diseases)
1. PURPOSE OF POSITION/ROLE
The Medical Therapeutic Area Lead (Rare Diseases) contributes to the development of medical strategy and provides Medical input into Brand Strategies and Medical guidance and governance for all Takeda Rare Diseases therapeutic areas ensuring support of the life cycle of all products. He or she provides scientific and medical support for key internal and external stakeholders, actively participates in the development of brand strategies for therapeutic area in accordance with internal corporate policy to ensure that the business objectives of nominated products are realized and the interests of the customer and Takeda are protected.
The person is also responsible for line management & enhancing capabilities of rare diseases medial team (advisors, MSLs) by coaching and developing emloyees based on capabilities, and actively engaging in individual development plan.
2. KEY ACCOUNTABILITIES AND RESPONSIBILITIES
Medical/Scientific Expert Role and Operational Support at Country Level:
- Take part in the development and achievement of strategy, tactics, and operating plan at country level advancing the marketing of company products and therapeutic area to ensure that medical plans in specified TA are successfully developed and executed to achieve short- and long-term objectives in alignment with the Global, Regional and Local business strategy goals.
- In compliance and close coordination with the Regional/Korea Medical Director develop key projects to drive products through proper dissemination of medical and scientific information in the country.
- Review regulatory, medical and safety materials from scientific point of view to ensure full compliance with local medical, regulatory and legal requirements. In compliance with ethical business principles provides scientific support and expertise to cross-functional team and other internal stakeholders with respect to materials creation and approval, advertising and educational programs, clinical research, medical information, regulatory issues.
- Manage issues that may adversely affect business. Challenge competitors’ claims and defending Takeda products and promotional materials when challenged
- Support Medical Director in shaping and executing the local annual Medical Budget, owning responsibility for appropriate spending in full alignment with local annual Medical Plan.
- Provide educational support inside cross-functional team at request in appropriate therapy area medical knowledge. When applicable, participates in processes of local medical colleagues development and supervision
- Contribute to development of Regional and Global Clinical Development plans with TDCA ensuring local clinical needs are addressed. Support TDCA in clinical trial associated issues in Korea (protocol/site feasibility questionnaires, recommend and support clinical trials centers assessments)
- Provide guidance and review all relevant and required medical contents in accordance with Takeda policies.
External stakeholders relations, Cross functional support and Risk management:
- Target, develop and maintain ongoing relationships with relevant bodies, institutes and key thought leaders for company to ensure that they always have the accurate, updated and comprehensive medical information aligned with Takeda strategies and to foster Takeda's efforts to establish and maintain relevant therapeutic leadership position, including but not limited to:
- Leads advisory boards/consultation meetings and develops the advocacy of the company brand and product brands
- Communicate with health/regulatory authorities in scientific matters
- Review and support Investigator Initiated Research (IIRs), management of associated relationships, including contacts in the appropriate therapy area, communication in study implementation through publication.
- To be consistent with regulatory requirement and SOPs, Medical Advisor provides Risk management of product safety issue, oversight of post-marketing surveillance closely working with medical colleagues, alliance partner and cross-functional team. ,
- Lead by example to promote cooperative and an inclusive way of working together within the medical team members and the cross functional teams
- Provide oversight of rare hematology, LSD and HAE medial team activity and support to deliver best-in-class medial affairs activity
- Engage and establish individual development plan through quality conversation with the direct reports.
- The employee shall also perform other tasks set by his/her superior within general framework of the employee’s job title
3. EDUCATION, EXPERIENCE & SKILLS:
Ideal candidate will have:
- Medical degree (e.g. MD)
- 3-5 years of prior Medical and/or Clinical Affairs experience in pharmaceutical industry
- Preferably 1year of experience in one of the relevant Therapeutic Area (s)- hemophilia, HAE, LSD
- Experience creating strategic medical plans & managing budgets
- Minimum 1 year people management experience
- Product launch experience
- Experience conducting advisory boards
- Managing scientific publications in relevant Therapeutic Area
- In-depth experience in clinical development
Skills & personal characteristics:
- Excellent leadership, managerial, interpersonal and relationship building skills
- Very strong scientific expertise, specifically in the therapeutic area
- Highly collaborative, confident and strong presence
- Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure
- Able to drive consensus across diverse stakeholders to achieve goals
- Ability to identify and proactively addresses issues before they reach crisis points
- Goal oriented, focused, energetic, and enthusiastic
- Passionate and committed in all undertakings
- Fluent in Korean language
- Excellent verbal and written communication skills in English; fluency in other languages is a plus
- Excellent presentation skills
- IT savvy and process orientated
- Good knowledge of healthcare systems
- A high level of knowledge of regulatory environment including key regulatory agencies and approval processes relevant to the country