Therapy Area Medical Lead - ME応募 後で応募 求人ID R0011077 掲載日 08/05/2019 Location: United Arab Emirates
- To build/ enhance Therapy area medical capabilities within the cluster’s markets so that Local Operating Company (LOC) medical teams have excellent technical knowledge and are able to bring patient-centric insights from Key Opinion Leaders (KOLs) to inform brand strategies and medical affairs plans.
- To lead Therapy area Medical Affairs (MA) strategies within THE MIDDLE EAST CLUSTER markets in collaboration with ICMEA, GEM MA and Global MA organizations
Build Therapy area medical capabilities across THE MIDDLE EAST CLUSTER, ensuring quality input in all planning processes
- Create an on-boarding program for THE MIDDLE EAST CLUSTER Therapy area Medics (including MSLs) in collaboration with GEM and global Therapy area
- Work with Area MSL Excellence Head to ensure MSLs are appropriately trained and confident in scientific expertise
- Coordinate with ICMEA, GEM and global Therapy area networks to ensure effective cascade of expertise from global/regional level to LOC level.
- Provide a dynamic platform to all Therapy area medics within THE MIDDLE EAST CLUSTER for best practice sharing and cross-border learning
- Provide medical leadership to the Therapy area portfolio within THE MIDDLE EAST CLUSTER and act as the THE MIDDLE EAST CLUSTER point of contact for all Therapy area related activities, projects, issues.
- Ensure medical training for allocated therapeutic area, e.g. training of MSLs and overall product team (Medical Affairs, Commercial, Market Access and Sales).
Maintain strong KOL interactions to ensure patient centric insights are brought inside Takeda to inform brand strategies and to establish Takeda’s reputation as a patient focused specialty care company
- Liaise with LOC medics to establish and manage external network of KOLs, and patient groups (where applicable) in order to inform Therapy Area (TA) strategy
- Drive KOL engagement programs throughout the lifecycle of all Therapy area assets
- Review Investigator initiated study proposals received within THE MIDDLE EAST CLUSTER to ensure global alignment and liaise with EM and global teams for approvals.
Create and implement robust Therapy area medical affairs plan for each asset
- Create a cluster level Therapy area Medical affairs plan by adapting the global medical affairs plans to THE MIDDLE EAST CLUSTER requirements.
- Plan & execute regional advisory boards to gather KOL s’ insights to understand treatment pathways and patient flows for therapy area of interest
- Ensure Therapy area activities and tactics are scientifically sound, aligned with medical strategic imperatives and relevant to LOC requirements and are executed to a high standard
- Drive alignment of medical strategies and medical affairs plans for all LOCs and support budget/resourcing discussions to meet commercial and medical needs of the Cluster.
- Ensure strategic relevance, timeliness and delivery of MA activities within THE MIDDLE EAST CLUSTER.
- Ensure a local publication plan is created and executed, if relevant, in accordance to the LCM of the asset(s) in alignment with Global and Regional Medical and Local Market Access functions.
Act as the Therapy area voice of THE MIDDLE EAST CLUSTER
- Provide inputs to ICMEA, GEM and global Therapy area business based on the needs of THE MIDDLE EAST CLUSTER LOCs.
- Collaborate with and provide medical inputs to Market Access colleagues on reimbursement and health policy-related projects to enable successful product launches
- Provide medical expertise to LOC Market Access, e.g. Pricing & Reimbursement Dossier creation
- Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance
- Provide scientific input into Marketing strategy and tactics
- Provide medical input for development of promotion material
- Assess scientific accuracy and validity of promotional and non-promotion material and its compliance with Takeda standards, SOPs and national laws
- Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate
Provide strong guidance for all clinical research activities in the Cluster
- Develop & review non-interventional and interventional study concepts and scientific content for protocols and accountable for approving study concepts and protocol for the use of LOCs
- Responsible for scientific integrity and adherence to GCP standards during execution of studies across The Middle East.
Takeda has traditionally been a primary care focused company, with very limited Therapy area expertise and experience.
- Takeda has entered multiple Therapy areas with complex, high science molecules. It does not have existing relationships with Therapy area KOLs in many markets.
- Very inconsistent level of maturity in the different countries forces a targeted approach focusing on the countries with more needs
- Medical teams in many markets do not have all the necessary experience of preparing medical plans, undertaking data generation activities or even conducting clinical research to GCP standards.
- There is an urgent need to build capabilities either through a mix of internal training and development or through external hire
- Compliance understanding and adoption is very weak in new markets where Takeda is just starting up
- Strong cross functional coordination required because of the fast pace environment
- Expansion in geographies where market information is very limited requires high level of in house intelligence and creativity to build strategies
KEY DECISIONS EXPECTED
- Prioritize initiatives and ensure that the THE MIDDLE EAST CLUSTER Therapy area medical budget is managed appropriately
- Guide countries across THE MIDDLE EAST CLUSTER in prioritizing Therapy area investments (both in terms of projects/activities and resourcing)
- Provide inputs to THE MIDDLE EAST CLUSTER Medical Affairs Head on all Therapy area related projects, issues to enable appropriate decision making.
- Manage the The Middle East Cluster Therapy area medical budget in alignment with Country Medical lead and Medical Affairs Head.
Geographical span: THE MIDDLE EAST CLUSTER
- Manage the overall MIDDLE EAST CLUSTER Therapy area medical strategy
- Manage the Therapy area medical operational budget
- Provide inputs at cluster level and to countries to help manage Patient Assistance
- Programs (PAPs) and Named patient programs (NPPs) for Therapy area assets
- Influence and guide a team of ~ 8 plus Therapy area staff in the LOCs
SKILLS & KNOWLEDGE
- Medical relevant-graduate degree
- Excellent knowledge of Therapy area
- Training in clinical research methodology, GCP will be an advantage
- 6+ years of total pharma industry experience in medium to large size reputed organization/s
- At least 3 years of Therapy area experience
- Experience in practicing Therapy area for few years is also a strong advantage
- Multi-country experience and understanding of pharmaceutical market within this region will be a strong advantage
Skills & Personal Characteristics
- Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure
- Excellent leadership, managerial, interpersonal and relationship building skills
- Excellent verbal and written communication skills
- Goal oriented, focused, energetic, and enthusiastic
- IT savvy and process orientated