Head of Medical Affairs, MY & SG

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Job Description

JOB SUMMARY

Responsible for providing overall strategic and managerial leadership for the Medical Affairs function for the LOC, including strategic prioritization on projects and tasks in partnership with Takeda’s business stakeholders. He/she will contribute to the achievement of business success by putting the patient’s needs and safety into primary focus.

The Head of Medical Affairs will drive alignment across the Medical Affairs team, provide supervision for team members, and collaborate with key cross-functional stakeholders (e.g. compliance, marketing, commercial, and regulatory) across all Therapeutic Areas.

This position is responsible for planning and implementing medical strategies and tactics, to increase the understanding of Takeda products amongst healthcare professionals in the region.

This position will represent Takeda’s medical / scientific image among industry and health care practitioners and entities.

This position is a corporate office based position with people managementresponsibilities.

PRINCIPLE ACCOUNTABILITIES

Overall

• Responsible for the overall medical function in the Local Operating Company (LOC) including strategic planning, resourcing, andbudgeting
• Provide medical expertise, governance and leadership to the Medical Affairsteam
• Leverage strong science to create compelling strategies that fulfill unmet medical needs, support successful product registration, and increase availability of Takeda’s medicine to patients
• Represent the Medical Affairs function to senior cross- functional leadership as well as externalstake-holder

Corporate Governance

• Oversee and ensure compliance of all responsible activities to relevant laws and regulations as well as internal standards andSOPs
• Serves as final signatory for medical approval of promotional materials for scientific meetings, symposia and other Medical Education activities, in accordance with applicable Codes of Practice and regulations as well as Takeda policies, within definedtimelines
• Ensure patients have access to life saving products whilst strictly complying with Takeda SOP’s and code ofconduct as well as MYSG Pharmaceutical Code of Ethics and applications, with an aim to comply with whichever code is stricter.
• Actively participate in local pharmaceutical industries association / societies committee meetings and analyze regular industry correspondence with follow-up and discussion with internal colleagues and other industry participants on relevantissues
• Enhance the company reputation and profile through an external focus, by representing the company on cross- companyboards

External Stakeholder Management

• Responsible for representing Takeda by providing an expert medical voice with external stakeholders asneeded
• Establish ongoing relationship with key opinion leaders (KOLs), government officials, healthcare organizations and ensure thatsignificantdevelopmentsinthefieldareidentifiedand monitored

Cross Functional Collaboration

• Ensure that string working relationships are fostered between Medical Affairs and other departments.
• Provide updates to senior management on Medical Affairs activities including status of clinicalprograms
• Collaborate with local senior management to develop strategic product plans to ensure timely entry of new products to the market and the ongoing market success of existingproducts
• Enable and support a positive team environment both within the medical team and with cross-functionalstakeholders and drive employee engagement.

Clinical Research

• Collaborate with clinical development teams and provide medical expertise to development asneeded
• Provide leadership and medical expertise in the development of clinical research programs in line with global strategies to support local product registration andmarketing
• Develop and support local data generation programs to support product registration andmarketing
• Proactively and reactively collaborate with clinical operations to ensure local patients are included in global trials as well as patient recruitment targets aremet

Patient Centricity

• Responsible for medical leadership in planning and implementing patient access programs as needed, as per local regulatory requirements, and in line withTakeda policies
• Provide medical expertise in the review ofadverse events locally and contribute to global pharmacovigilance activities as needed
• Ensure patient safety is prioritized and that adequate QA and PV systems are installed andimplemented
• Coordinate QA- and PV-activities and ensure QA- and PV- SOPs are in place and are strictly followed. This includes managing product related medical safety issues and provide input on product-related quality issues and incidents to the globalPV-team

Structural Organization

• Responsible for the financial management of the R&D program and medical plans, including budget planning, resource allocation and preparation of monthly / quarterly reports
• Ensure effective team communication and alignment throughout the Medical Affairsteam

EDUCATION, EXPERIENCE, AND SKILLS

Education​

• A medical degree is preferred.

Required Experience

• 10 years of Clinical or Medical Affairs experience in pharmaceutical industry
• Preferred experience supporting Vaccines TA / Portfolio.
• 5 years+ experience in people management

Preferred Experience

• High reputation in industry with established network
• within the Medical Affairs community that will attract high- calibre professionals into the organization
• In depth experience of Medical Affairs with quality achievements in life cycle management of medicines.
• In depth experience in clinical development and data generation including real world evidence, regulatory, market access and drug reimbursement process where applicable.
• Business Development experience from Medical Affairs perspective.

Skills & personal characteristics

• Excellent leadership, managerial, interpersonal and relationship building skills
• Solid people management skills and a desire to develop team members
• Highly collaborative, confident and strong executive 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
• 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

Travel requirements

• Ability to drive or fly to various meetingsites
• Frequent overnight travel, including weekendcommitments

Locations

Selangor, Malaysia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time