Medical Head (Nigeria) at Sanofi

Ref: R2613041
Reports to: Foundation Medical Head - Africa, Middle East, & Turkey
Function: Medical Affairs
Grade: L4:1

Job Description

• The Foundation Medical Head (FMH) is the single accountable person for all medical issues in a Foundation country that are applicable across multiple GBU units and/or functions.
• The FMH role is a coordination/management role (vs a technical expertise role) to ensure flawless operation and advancement of the medical function in a Foundation country / MCO.

Roles and Responsibilities
Drive “one Sanofi medical” externally:

• Represent a unified medical voice for medical/scientific external non-BU specific engagements and partnerships at the country level in alignment with Foundation Country Lead and Public affairs
• Act as the medical spokesperson for non-therapy area specific topics with media.
• Be the accountable medical contact for Health Authority (HA)/GxP inspections to facilitate both process execution and coordination of corrective actions to address the findings together with BUs and functions.
• Be the internal focal point to:
  • Coordinate medical actions in the context of Code Complaints (in small countries where FMH is the only office-based medical staff, execute medical actions with the respective regional BU medical support).
  • Coordinate medical actions in the context of cross-BU litigations.
• Manage cross-BU contributions requests and donations.

Enable Cross-BU Functional Medical Excellence:

• Cross -GBU medical activities include but are not limited to the following: Medical Governance (Audit & Monitoring, Programs & Systems…), Medical Excellence (Transparency, Compliance, Congress & Event), non-TA specific Scientific training.
• Ensure implementation of global medical policies and standards (develop country-specific SOPs as per local needs/, in collaboration with quality department).
• Chair the Medical Regulatory Pharmacovigilance Quality (MRPQ) council.
• Steer transversal initiatives, including simplification and change management.
• Organize medical days to foster scientific exchange, learning and best practice sharing.
• Be the point of contact for global medical functions through the Foundation Medical Head – Africa, Middle East & Turkey to facilitate consistency of local execution of global processes and Medical activities cross-BU.

People:

• Be accountable for performance of cross-BU medical functions reporting to her/him, as appropriate.
• Evaluate performance of BU medical functions related to FMH activities. Country BU medical functions will have up to 10% of their individual objectives allocated to support FMH activities.
• Share the assessment with the respective Region/ Zone Medical Heads
• Facilitate talent management across BUs/succession planning, convene their counterparts and HR to ensure talent discussions is taking place at least once a year, including Regulatory, Pharmacovigilance, Quality and E&BI
• Develop talents and potential candidates in light of PtW culture in full alignment with HR.

Sign-off:

• Local medical Standard Operating Procedures (SOPs).
• Local transparency reports (in collaboration with the transparency office).
• Compassionate Access to Sanofi life-saving medicines across all BUs.

Medical Compliance & Transparency:

• Ensure compliance (Process Development and implementation, Code Training, Monitoring and Audit)
• Be the medical Contact for Internal control, Audit and E&BI teams to facilitate both process execution and coordination to ensure that the corrective actions are implemented by the accountable BUs and functions to address the findings.
• Be accountable for consistent adherence to Fair Market Value (FMV) standards and processes.
• Monitor the number of Health Care Professional (HCP) engagements per quarter in the country; inform on regular basis cross-BU Heads, cross-BU Medical Heads and Ethics and Business Integrity (E&BI):
  • FMH is responsible for reviewing and monitoring the number of contracts and the expenditures.
• Act as country Event management tool validator (when the FMH is the only office-based medical). The FMH can delegate this approval to other people as appropriate including Medical GBU heads for example.
• Sign -Off local transparency reports (in collaboration with the transparency office).

Other:

• Make final decision in case of misalignment on promotional vs non-promotional qualification.

Operating Model - Committees:

• Chair the cross-BU Medical Regulatory Pharmacovigilance Quality (MRPQ) council, including Market access as appropriate. In case of MCO, the FMH will contribute to the MCO MRPQ council.
• Represent a unified medical voice across BUs and functions on country leadership teams (i.e. E&BI committee; participation to other committees on an ad hoc basis, as relevant).
• On an ad hoc basis participate to Country council
• Take part to the FMH community forum.

Key Responsibilities and Duties for This Job

• Support NG initiative for GenMed thought leader advocacy and relationship-building.  The FMH  is responsible for cultivating current and future experts in academic and clinical medicine at regional and national levels. Through these relationships, the team will gain meaningful expert insights that influence priority areas of the product Life Cycle Planning team in support of business, clinical and scientific strategy.
• Liaise regularly with internal business leaders to share feedback and issues from the disease area experts.
• Support the development of Investigator sponsored studies. Through expert relationships, the FMH will facilitate the initiation of research projects and ensure that hypothesis testing is clearly defined and within priority areas consistent with the strategic development objectives of the portfolio of products.  He/she will be responsible to ensure the successful execution of appropriate processes for review, approval, management and support of studies while maintaining investigator independence according to regulatory and compliance guidelines.
• Ensure the strategic and substantive input to publication planning and execution to ensure that all data on the portfolio of products generated by company or investigator-sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner.
• Provide Medical Affairs support to the review of requests for grants and sponsorships.  Ensure that review and approval processes strictly follow compliance guidelines.
• In anticipation of product launch, the FMH will ensure that he/she and his/her team provide medical support, education and guidance to commercial, marketing and sales teams.  Provide medical support to promotional and legal review committees as needed.
• Represent Sanofi GenMed at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders.
• Maintain knowledge of the respective disease area marketplace, stay current on leading edge products development and lifecycle management efforts and provide perspective to the business on the treatment landscape.
• Define and develop needs analyses for the Medical Advisors and Medical Science Liaison (MSL) functions, as relevant to the respective portfolio to ensure that those carrying out the medical function activities are optimally educated to be experts on the respective disease areas and the competitive landscape.
• Provide ongoing support for company sponsored trials in alignment with Clinical Development strategy.  Ensure that conduct is in keeping with regulatory guidelines.
• The FMH will ultimately, via opinion leader network relationships, ensure the initiation of research projects within priority areas as determined by the product Life Cycle in support of business, clinical and scientific strategy.
• Through an integrated and cross-functional approach, ensure that medical projects are developed and executed that support maximizing the lifecycle opportunities for the respective products through enhanced value offering including line extensions and new patient access opportunities.
• Responsible for the development of a local medical plan to optimize commercial success of Sanofi GenMed products and value offering to patients.
• Ensure the contribution of Medical Affairs in the development of market access strategy and submissions for GenMed products.
• In collaboration with Clinical operations optimize performance of clinical studies and appropriate management of operational budgets.
• Ensure adequate medical support to regulatory affairs and pharmacovigilance.
• Ensure optimal support to Business Development activities, especially by providing the necessary expertise to allow accurate scientific evaluations of opportunities.

Requirements
Qualifications:

• Advanced degree in medicine (MD or equivalent)
• Advanced degree in biomedical or health-related sciences (PhD, PharmD, DDS, DMD, MSc, or equivalent) in exceptional cases.

Experience:

• Not less than 4 - 5 years of experience in the biotech/pharma industry at the local level or regional level within Medical Affairs, with experience of working with cross-functional in-house and field-based teams
• Thorough understanding of the commercialization process and the involved stakeholders internally (e.g., medical, regulatory, safety, compliance, commercial, legal, and quality functions) and externally (e.g., reimbursement or competent authorities).

Skills and Knowledge:

• Strong strategic and business acumen and good understanding of the success factors for all Sanofi businesses locally;
• Forward-thinking and strong knowledge of strategic interplays that influence patient and payer decisions;
• Strong communication, influencing and conflict-resolution skills;
• Excellent interpersonal skills;
• In-depth knowledge of the organization and good connection with global and regional Sanofi decision-makers;
• Courage to allow for difficult trade-off decisions when required;
• Strong network / recognition by key external stakeholders (public, patient groups, KOLs) to ensure maximum legitimacy as a country leader;
• Strong executive presence with leadership recognition by Sanofi employees in the country.
• High ethical standards, and track records of integrity in conducting business
• Fluency in English / French is an additional option.

Aptitudes:

• Pragmatism, “make it happen” mentality
• Eager to embrace changing environments and lead new initiatives
• Agility, Resilience
• Leadership, Perseverance
• Emotional intelligence.