Head Medical Affairs

Head Medical Affairs

Daiichi Sankyo Europe

Brussels, Belgium

Context

The Head Medical Affairs leads the DSBE SBU Medical Affairs and Information/pharmacovigilance team organization, is the legally responsible person for information and publicity (RIP) in Belgium and Luxembourg.

The Head Medical Affairs follows the medical aspects of the lifecycle process of a product: from clinical trials to post-marketing studies. He/she ensures medical contact persons for external medical corps (key opinion leaders, specialists, general practitioners…) and internal DS (national and international level) are appointed and scientific communications happen in an appropriate way, in line with rules and regulations.

The Head Medical Affairs is part of the Belgium Leadership team, cardiovascular leadership team and directly to the DSBE Country Manager.

Purpose of the job

Translate the Medical Affairs mission and vision to the DSBE environment. Develop and implement the medical strategy for products which are on promotion or pre-marketing and implement the strategic medical plan according to relevant ethical and legal rules. Support the HQ in the local implementation of clinical trials. Contributes to leading the way in building trust in the pharmaceutical industry.

Result areas

Sets the customer- and patient-focused medical strategy for DSBE SBU

• Provide support to top management as a strategic business partner for all medical aspects by participation to Belgium Leadership team, management teams and medical/marketing/sales committees, in order to assure relevant medical aspects (including regulations and requirements) are met. Is member of European medical directors team;
• Lead, develop and motivate all employees within the department including manpower planning, recruiting, coaching, developing and team management;
• Ensure in-depth medical expertise in relevant therapeutic areas is present in the team (via analysis of EBM, participation to congresses, peer-to-peer discussions with KOLs...);
• Maintain and encourage a constructive relationship with KOLs. Ensure insights are captured (via peer-to-peer discussions and/or advisory boards) and communicated to the DSBE organization. Plays an important, external-oriented, role in the image building of the company as contributor to advancing medical practice (products, evidence and services) within the scientific community. Organize the set-up of educational programs, from capturing needs to effective implementation;
• Set the medical strategy for DSBE in alignment with the European medical affairs plans. Prepare the elaboration and ensure the implementation of the business plan, medical budget and medical product plans;
• Be the medical contact person for DSBE, where needed in collaboration with business partner(s). Collaborate closely with sales and marketing functions. Build scientific and competitive knowledge in the organization to enable effective decision-making, customer engagement and brand performance.

Grow and communicate about product and therapeutic area knowledge (DSBE SBU)

• Follow the medical aspects of the lifecycle process of SBU products: from pre-authorization studies to post-marketing studies and registries. Plan and ensure execution and documentation of clinical research studies or pharmaceutical substances as required by the international responsible department. Be responsible for local DS sponsored studies where needed. Ensure requests for collaboration for IITs are captured, filtered and adequately handled;
• Organize the adequate handling of medical information upon unsolicited request by HCPs or internal departments;
• Ensure company, pipeline and product data presentations to HCPs are held and educational projects are set up, implementing innovative communication channels in a hybrid environment;
• Support marketing departments in maximizing the potential of company's products, through generation, interpretation and communication of medical and scientific information and through effective assessment of training needs and providing training sessions to explain the specifications of products and studies.

Is the Responsible person for Information and Publicity. Leads the Pharmacovigilance department. Conduct all activities in accordance with the applicable laws, rules and regulations. Educates the company and supervises implementation (DSBE)

• Ensure all scientific services (in collaboration with the local safety officer) are provided as required by law;
• Supervise all promotional and information activities, including but not limited to promotional material approval, samples distribution, medical information and mDeon requests and set processes in place to ensure compliance with rules and regulations, as responsible person for Information and PublicityEnsure company members are adequately trained on rules and regulations related to external communications;
• Ensure expertise related to deontological codes, EFPIA and pharma.be, as well as DS internal codes and policies, is present in the team and relevant topics are communicated to the organization;
• Appoints the Local Safety Officer (LSO) and deputy(ies). Ensures the pharmacovigilance activities in DSBE are executed in accordance with applicable laws, rules and regulations with flawless adverse event reporting and adequate training.

Profile

Experience

• Minimum of 5-10 years of experience, with a preference for recent and relevant experience within the pharmaceutical or biotech industry;
• Track record in negotiating and interacting with different medical professionals and high-level executives and potentially even policymakers; preference for someone with an international network in the core markets of Daiichi Sankyo;
• Successful in driving a growth and change agenda in ambiguity environment;
• Proven track record as an effective team builder and leader, with the ability to influence, motivate, mentor and direct; particularly adept at coaching technically orientated individuals into a more commercial mindset;
• Track record of management of a medical team.

Qualifications

• MD/PhD with a minimum of 5 years experience in Medical Affairs in the Pharmaceutical Industry ideally with relevant clinical, scientific and/or medical affairs experience preferable in cardiovascular;
• Exhibits a high degree of emotional intelligence and appreciation of diversity and inclusion. Understands and is a true believer in the power of teamwork;
• Very good communication skills (storytelling);
• An expert understanding of the Belgian health care delivery system, including the managed care arena and its impact on patient care, local medical care and the pharmaceutical industry. Ability to identify the unmet medical, educational, and research needs at a local (& regional) level in the medical community;
• A hands-on visionary with an inspiring and empowering and empathic leadership style;
• Trustworthy positive personality fitting with Daiichi Sankyo and the shareholders;
• Strong business, operational and financial acumen.

Competences

• Quick in getting the confidence of people by being a great listener, involved and open;
• Team player;
• Top-tier analytical skills, strategic thinking and strong project management skills with demonstrated ability to manage projects and/or colleagues in the successful implementation of business-critical projects;
• Proactive, entrepreneurial and solution-oriented;
• Fluent in English, French and Dutch;
• Demonstrates ability to deal with ambiguity and thrive in an ever-changing environment.

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Belgium      Clinical Research      Manager and Executive      Medical      Medical Advisor      Pharmacovigilance and Medical Information      Daiichi Sankyo Europe