Medical Affairs Head at Takeda

Who We Are Looking For

The Medical Affairs Head in close collaboration with the General Manager, Health System Liaisons (HSLs), Patient Value Access (PVA) and Ethics and Compliance is responsible for

• Providing strategic leadership of SA/SSA Medical personnel; manage and develop Medical team to achieve optimal performance
• Provide strategic guidance to the SA/SSA team and define coaching opportunities to successfully execute on priorities.
• Contribute to the achievement of business success by putting the patient’s needs and safety into primary focus
• Ensure compliance of LOC / MCO and medical team to the code of conduct, corporate philosophy, relevant laws and regulations as well as SOPs and policies
• Represent SA and SSA medical functions in a professional and competent manner towards internal and external stakeholders; ensure alignment, collaboration and proactive sharing of relevant information across all departments
• Lead overall company vision and direction for the portfolio at LOC level in SA and scientific office in SSA.
• Broadening access through innovative evidence generation; facilitating coordination and integration of different medical data and types of knowledge and articulating clinical and economic value as well as providing medical training, managing engagement of KOLs and supporting access programs.
• Actively assessing the healthcare landscape for both SA and SSA, meeting with key stakeholders/access influencers to understand the health system gaps, and working closely with the HSL and key stakeholder to identify effective solutions to address gaps

Required Qualifications And Experience

• Extensive medical experience, Medical doctor
• Advanced degree in management, such as M.B.A., M.P.H. or M.H.A. is an advantage
• Min 5+years’ experience working in a team environment and in a supervisory position managing direct reports
• Min 6 years of pharmaceutical industry experience

Accountabilities
Leadership

• Provide direction and input into the overall strategic roadmap of the SA LOC and SSA strategy incl. building of required capabilities for the futures
• Build capabilities ensuring development of medical team through regular coaching, mentoring and team IDP’s.
• Ensure medical plans are aligned cross-functionally and aligned with the company / local strategy and is delivered on time and on budget
• Leverage strong leadership to develop and actively deploy talent retention strategies, binding highly qualified employees to the company and to offer stimuli for reaching ambitious objectives
• Support on-boarding, training and knowledge transfer within the medical department across countries (SA/SSA) providing an upskilling on areas of improvement as agreed within the leadership team
• Ambassador for Corporate Philosophy and Takeda-ism
• Lead local processes to hire new medical personnel in both SA/SSA

Medical/Scientific Affairs

• Responsible for adherence to Global / Regional and local Compliance Standards for the Non-Commercial (Scientific) processes
• Guarantee scientific accuracy and adherence to ethical and industry standards regarding medical information, medical staff and sales force training, promotion of products marketed in accordance with the local Drug Law and Takeda’s standards / SOPs
• Oversee development of local tactical medical plans in line with the FH strategy and execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.)
• Liaise with other Department Heads to ensure common understanding of customer needs and alignment on applied strategy
• Establish and maintain –in alignment with Regional and Global Medical Affairs- strong relationships with Key Opinion Leaders (KOLs) as well as establish network including medical, clinical and academic community, authorities, pharma industry, payers and other relevant stakeholders
• Establish and develop Medical Managers/ MSL in the country including territory alignment, targeting and segmentation
• Develop HCP mapping and segmentation principles as basis of MSL territory alignment in coordination with commercial excellence where applicable; set standards for local/regional HCP mapping by MSLs
• Provide medical contribution to Tender Business offers and negotiations; support local Business Development/In-licensing activities with scientific evaluations
• Anticipate or identify changes in the marketplace that may provide scientific, medical, regulatory and/or commercial opportunities for Takeda
• Provide medical contribution to market access, reimbursement applications and negotiations
• Act as media Spokesperson on medical topics, therefore act as Takeda representative in front of competent authorities for subjects under his/her responsibility
• Act as communication link between local Departments and Regional and global medical functions
• Supervise Medical Education, Publications, Insight Generation activities
• Responsible for the timely and competent handling of all scientific/medical aspects related to all marketed and developing Takeda products in accordance with appropriate international and regional Guidelines/Directives, local law and Takeda standards/SOPs
• Develop and oversee execution of medical training of LOC / MCO personnel
• Establish a KPIs system for MSLs and operationalize in CRM

Clinical Research

• Where applicable head of medical affairs will be responsible for the development of the local clinical research plan (both interventional and non-interventional, including RWE) according to gap analysis and in alignment with Global and local functions (e.g. Market Access)

Medical Affairs Responsibilities Interfacing With Pharmacovigilance

• Report safety information (e.g. Adverse events, special situations, products complains, other important safety information, etc.) from various sources (e.g. Medical information requests, interaction with HCPs, etc.) to LOC PV within the timelines as per the applicable SOPs.
• Provide input on local literature search terms & criteria and the identification/assessment of the relevant local scientific journals to be screened by LOC PV for reportable safety information.
• Contribute to the creation, update & implementation of local Risk Management Plans & additional risk minimization measures/materials – as applicable.
• Notify LOC PV of local studies & programs (e.g. MACS studies, IISRs, early access programs, etc.) to satisfy any PV requirements as per the applicable SOPs
• Provide disease & product medical training to LOC PV staff – as necessary.

Key Skills, Abilities And Competencies

• Technical expertise and strong understanding of medical affairs deliverables
• Collaborative leadership Advanced communication skills to build and shape team and external relationships (with KOLs, policy makers, health economists, scientific societies, etc.)
• Compliance insights Profound understanding of compliance and medical Ethics, ability to navigate complex situations balancing SOPs, regulations, our values and business interests
• Business acumen coupled with drive for results, holding self and others accountable for commitments that align with our short- and long-term goals
• Patient centricity Ability to understand the customers' needs, leading complex collaborations successfully and creating genuine win-win solutions
• In depth knowledge of PV reporting and enterprise risk management
• Knowledge of healthcare systems, medical quality assurance, quality improvement, risk management
• Strong project management skills ability to manage multiple projects simultaneously
• Ability to lead change

Leadership Capabilities

• Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and business
• Creates the environment that inspires and enables people to move the organization forward
• Focuses on the few priorities that matter most and delivers superior results
• Elevates the capabilities of the organization for now and the future
• Direct reports 4
• Indirect Reports 4

Complexity and Problem Solving

• Comfortable with complexity and ambiguity, finds solutions to tough problems, has broad interests, highly curious
• Delivers results, resourceful, inspiring, has a significant presence
• Ability to challenge company staff to maintain and validate and prioritize patient-centric and patient focus in all work
• Confident and able to engage with disease area experts , health officials and other stakeholders
• Will work closely and collaboratively with various internal stakeholders

Internal and External Contacts

• This function will advise, consult as well as regularly coordinate internal and external interactions.

Other Requirements

• Registered with the HPCSA
• Valid South African Driver’s license for motor vehicle.
• Own vehicle that can be used for business.
• Local travel to ensure execution excellence optimizing stakeholder engagement with some international travel