BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description: 

The Country Medical Director will be accountable for medical affairs activities for the assigned territory and will play a key role in the design and implementation of a respective Medical Affairs plan to provide the scientific support for marketed products and products in development. In addition, this role will encompass the role of the South African QPPV. This position is responsible for all aspects of patient safety within South Africa, as the appointed South African QPPV. As such, the appointee will play a significant role in the establishment of the local PV system, in conjunction with Global Patient Safety strategy as well as being responsible for the pharmacovigilance of all medicines of BeiGene South Africa.

S/he will work in accordance with the South African regulations, organizing and executing medical affairs and pharmacovigilance activities.

Essential Functions of the job:

S/he will support local data generation, data dissemination and HCP interactions. S/he are active member of the local leadership team assuring alignment on a country/cluster level as well as the New Markets medical affairs leadership team. Specific responsibilities include but are not limited to:

Medical Affairs

Lead the medical affairs organization for the assigned Country clusters with responsibility for the generation of medical strategy development. Build and maintain relationships with local HCPs and collaborative groups relevant to indication areas in focus.Provide medical insight into promotional material along with learning materials for internal and external use and actively contribute medical and scientific input to relevant internal Brand(s) and Managed Markets teams regarding product strategy.Provide local input into investigator initiated trial strategies, medical affairs strategies.Provide scientific review and input into reimbursement and local regulatory submissions.In addition to generation of scientific data to support medical claims, provide input for the generation of health economic outcome data to support reimbursement. Serve as Scientific leader with local leadership and, as required, managerial support responsibilities for scientific staff such as safety, regulatory, technical operations (CMC) and local clinical development staff.  Liaise and coordinate issues and development of such staff with their headquarter primary managers and ensure that local needs are addressed.Have responsibility for the provision of input to Research & Development to assist with the lifecycle management of the products for the Country/Cluster, including developing and disseminating appropriate scientific data and ensuring all Medical Affairs activities are conducted with the utmost integrity.Serve as a spokesperson for product launches and medical issues in the Region, in conjunction with Corporate Communications.Oversee the alignment of medical strategies and communication plans, support resources and budget to ensure the medical and commercial needs / opportunities of the Country/cluster’s haemato-oncology/ oncology business are met.Work with medical staff to support integration and communication to regulatory and development teams with strategic medical input where appropriate; ensure regional medical affairs activities are scientifically sound, within relevant guidelines, and of a high standard.Ensure compliance with all BeiGene internal and local/regional directives and regulations for, amongst others, the release of promotional material, medical representative training materials, and medical

QPPV, South Africa

Responsible for establishing the national PV system as the appointed South African QPPV.Acts as the point of contact for all pharmacovigilance enquires from SAHPRABe available to SAHPRA on a 24-hour basisResponsible for ongoing legislation monitoring, subsequent impact assessment and recommendations relating to operational updates/modification.Maintains knowledge of local and international regulatory requirements, pharmacovigilance science and process best practice.Accountable to ensure the appropriate pharmacovigilance documents are prepared and submitted to SAHPRA. These include but are not limited to ICSRs, PSURs, ongoing pharmacovigilance evaluations during post-registration period, company sponsored pre- and post-registration study reportsResponsible for establishing and monitoring local & regional communication channels for the exchange of safety information; triages information appropriately across Global Patient Safety and interfacing teamsEnsures any requests from SAHPRA for additional information deemed necessary for the evaluation of the risk-benefit ration of a marketed product is provided to SAHPRA.Monitor the benefit risk profile of assigned portfolio and providing evaluation to the Global Safety Management Team (SMT), or relevant safety governance committeeProvides input into the preparation of regulatory action in response to emerging safety concernsMeaningfully contributes to global Qualified PV Persons Council, wherein local/regional PV updates and best practices are exchanged and where South African QPPV can maintain oversight over the PV system and the safety profiles of the marketed productsMonitors and communicates in a timely manner with GPS functions about local Risk Management Plans (RMP) and risk minimization activities relevant for the territoryAccountable for ensuring appropriate and accurate information in the local PSMFMaintains awareness of local activities such as, but not limited to, market research, patient support programs, investigator sponsored research, non-interventional studies, compassionate use programs and named patient supplyEnsures awareness, review of protocols and results of post-authorization safety studiesEstablishes appropriate back up coverage is in place and adequately trainedEnsures PV training and its documentation for all staff at national levels as appropriateAccountable for the development, maintenance and approval of country and/or regional SOPs, matrices and work instructions, in accordance with global and local regulation and company practices Ensures the monitoring of local BeiGene sponsored websites and digital mediaSupports all inspection-readiness activities; supports during inspections and auditsReviews new or updated local PV Agreements and/or Safety Data Exchange AgreementsWorks with business partners and vendors to ensure the maintenance of the PV system(s)

Key Relationships:

GPS Leadership teamGPS Safety Science & Epidemiology (Product Safety Leads, Safety Scientists and Epidemiologists)GPS Safety OperationsRegulatory AffairsMedical AffairsQuality AssuranceApplicable Commercial division

Experience / Qualifications:

M.D. physician or scientific degree with significant experience in all aspects of clinical trials and professional knowledge and skills working with hemato-oncology and oncology therapeutics in solid tumor and hematologic indications.Relevant pharmaceutical or related industry experience (7-10 years) in haemato-oncology /oncology with proven track record as country medical director with contribution to commercial, medical and/or clinical development strategies (in country).Solid peer relationships with and exposure to external scientific and clinical experts and HCPs; demonstrated ability to proactively engage internal and external leaders and serve as a medical expert for the haemato-oncology/oncology disease area.Intimately familiar with applicable rules and regulations and actions of French and other regulatory bodies within the assigned Region.Recognized expertise in clinical and/or research experience (including publications) in therapy area is desired; specialty training and/or clinical experience in haemato-oncology/oncology is highly preferred.Proven ability to translate and appropriately align commercial and scientific goals and objectives and to interact productively with both commercial and scientific colleagues.Knowledge of Good Pharmacovigilance Practices (GVP)Highest ethical standards in corporate medical governance.Experience delivering effective and persuasive communications on complex and controversial topics to both corporate management and scientific audiences.Strong interpersonal skills to allow for successful interaction with peers across the organization to achieve corporate goals.Excellent written and oral communication skills.English proficiency a must; fluency in the primary language of the Region is essential.Ability to travel.

Responsibilities:  

The incumbent will manage all medical affairs related matters, train and support the field team.  The incumbent will also ensure that medical affairs strategies create value for BeiGene products and are aligned with global brand planning, medical strategy and ongoing late stage development lifecycle management plans. 

Education Required:  M.D. physician with significant experience in all aspects of clinical trials and professional knowledge and skills working with hematology and oncology therapeutics in solid tumor and hematologic indications.

Reports To: Country General Manager, South Africa 

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.