Basic Purpose of the Position:
Lead the Therapeutic Area Clinical Development,Medical Affairs,MSL and Early Asset organization covering the whole portfolio including pipeline and marketed products in dedicated therapeutic areas (TA)
1. To ensure medical affairs team collect scientific insights, generate relevant data, maintain clinical and scientific expertise and deliver information and advise to customers and internal stakeholders according to global strategies and internal and external legal/compliance, regulatory and quality standards;
2. To provide strategic direction for clinical development in ROPU T.C.M., incorporating both corporate portfolio and local needs, and promoting specific local clinical development programs to address highly unmet medical needs in ROPU T.C.M;
3. To lead implementation of TA strategies; to identify gaps in processes while implementing the TA strategy, and propose concrete actions to fulfill the gaps;
4. To ensure efficient collaboration within Medicine and across HPBU, and maintain oversight over planning and execution of clinical development and medical affairs activities, following agreed and optimized business processes and utilizing systems, platforms and innovative technologies;
5. To ensure appropriate resource for the team including head count and budget with high agility; to attract, maintain and develop high caliber talents.
Accountabilities:
Set strategic direction for clinical development in ROPU T.C.M., incorporating both corporate portfolio and local needs
Lead implementation of TA strategy; to identify gaps in processes while implementing the TA strategy, and propose concrete actions to fulfill the gaps
Oversight the progress of clinical development plans and assist local asset team/evidence team getting endorsement from corporate Therapeutic Area and Asset Teams also local governance committee on TA development projects
Oversight the preparation and interaction with CDE during pre-IND, CTA, pre-NDA and NDA, and advisory board meetings and investigators meetings for development programs
Optimize/maintain the governance process for local portfolio/projects management
To guide TA MA group to make strategic medical plan and contribute to brand plan. To provide tactical and strategic inputs to develop scientific partnerships with KOLs and key medical organizations and business/technical expertise to Product Life-cycle Management towards ethical promotion of assigned products.
Establish and expand the clinical development & Medical affairs team with high capable talents, by attracting, retaining, and developing key talents
Lead and coach assigned TAs group members and keep enhance the functional expertise.
Anticipate and manage resource (budget and headcount) needs agilely to ensure the organization is appropriated sourced.
Required Capabilities:
Master degree or above, preferable MD or Ph D in medicine related fields
1. In depth knowledge of drug development life cycle, with >=10 year experience in medical department of multinational companies with >=8 year experience in both clinical development and medical affairs are needed
2. >= 5 years people management experience preferred.
3. Solid Therapeutic area knowledge.
4. Excellent communication skill and strong leadership
5. Fluent to speak, read and write in English. Strong written and verbal skills and well-developed multi-cultural sensitivity.
6. Track record of accountability, agility, and Intrepreneurship and willingness of taking smart risks.
7. Able to work independently as well as in cross-functional groups (internal and external)
8. Strategic thinking and financial knowledge
9. Strong ability to create network with external experts and other key stakeholders.