Head of Medical Affairs

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Job Description

Job Title: Head of Medical Affairs

Location: Jakarta, Indonesia

About the role:

• The Head of Medical Affairs is responsible for providing overall strategic and managerial leadership for the Medical Affairs function for the LOC. 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 country.
• This position will represent Takeda's medical/scientific image among industry and healthcare practitioners and entities.
• This position is a corporate office-based position with people management responsibilities.

How you will contribute:

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

Strategic Planning

• Identify, develop and implement high-value strategies for product life cycle development and expansion across Takeda's product portfolio
• Provide oversight, input, and final approval of TA specific Medical Plans
• Plan for, prioritize, and resource the Medical Affairs team to provide appropriate support for pre-market launches and post-market medical programs, including strategic and tactical planning and design, implementation and timely completion of phase 4 studies, and addressing post-marketing needs
• Oversee Medical Affairs' contribution and provide input as needed into the development of Brand Plans
• Provide medical input into Business Development projects, including medical assessment of the target molecule and overall feasibility of the project from a Medical Affairs perspective

Corporate Governance

• Oversee and ensure compliance of all responsible activities to relevant laws and regulations as well as internal standards and SOPs
• Serves as a 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 defined timelines
• Ensure patients have access to life-saving products whilst strictly complying with Takeda SOPs and code of conduct
• 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 relevant issues
• Enhance the company reputation and profile through an external focus, by representing the company on cross-company boards

External Stakeholder Management

• Responsible for representing Takeda by providing an expert medical voice with external stakeholders as needed
• Establish ongoing relationships with key opinion leaders (KOLs), government officials, and healthcare organizations and ensure that significant developments in the field are identified and monitored

Cross-Functional Collaboration

• Ensure that the relationships between Medical Affairs and other departments are managed optimally
• Provide updates to senior management on Medical Affairs activities including the status of clinical programs
• 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 existing products
• Enable and support a positive team environment both within the medical team and with cross-functional stakeholders

Clinical Research

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

Patient- Centricity

• Responsible for medical leadership in planning and implementing patient access programs as needed, as per local regulatory requirements, and in line with Takeda policies
• Provide medical expertise in the review of adverse events locally and contribute to global pharmacovigilance activities as needed
• Ensure patient safety is prioritized and that adequate QA and PV systems are installed and implemented
• 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 providing input on product-related quality issues and incidents to the global PV 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 Affairs team

People Management

• Provide oversight and leadership to the Medical Affairs team by ensuring that appropriate structures, systems, competencies and values are developed
• Determine headcount requirements for the Medical Affairs team, and lead the identification, assessment, and selection of suitable candidates for positions within Medical Affairs
• Collaborate with direct reports to set and achieve appropriate KPIs
• Provide and/or facilitate regular coaching of direct reports to improve capabilities and identify areas for future training, including in-field coaching to MSL direct reports (if applicable)
• Support people development by ensuring all Medical Affairs team members have an Individual Development Plan (IDP), career development opportunities, dedicated time for personal career development, and create succession plans for key roles

What you bring to Takeda:

Education

• MD or MBBS is preferred.
• Pharmacist is welcomed
• Proven experience and expertise for non-medical candidates will also be considered favorably.

Required Experience

• Minimum 15 years of Clinical or Medical Affairs experience in the pharmaceutical industry
• Vaccine and/or innovative medicines experiences are preferred.
• At least 5 years of experience in senior leadership role

Preferred Experience

• High reputation in the industry with an established network within the Medical Affairs community that will attract high-caliber 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 processes where applicable
• Business Development experience from a 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 address 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 the regulatory environment including key regulatory agencies and approval processes relevant to the country
• As with all Takeda positions, the Head of Medical Affairs is expected to conduct themselves in line with the Company culture and Takeda-ism

Travel Requirements

• Ability to attend to various meeting sites, both domestic and overseas
• Frequent overnight travel, including weekend commitments

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

IDN - Indonesia Remote

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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