As a Clinical Epidemiologist within Keyrus Biopharma, you will join a team on client's site to participate in the development of a worldwide epidemiological strategy and research to accomplish the client's strategic programs.
You will participate in task forces/capabilities framework/working groups, development of policies/SOP/guidances related to epidemiological activities.
You will also assist with Internal adaptation of procedures & policies related to biomedical research with a focus on epidemiological research to guarantee compliance with international regulations.
Besides, you will partner externally with international initiatives (including Public Private Partnership).
Role and main tasks:
- Coordinate and implement epidemiological activities and critical studies for product development and access in line with the company's strategic programs
- Finalize medical plans and regulatory post approval plans for late development sand life cycle products.
- Finalize global Epidemiology plan for early products
- Bring epidemiologic expertise and methodology to influence across phases of product development in one or more disease areas
- Provide epidemiologic consultation at project & access/medical plan team level
- Manage the internal presentation of the company's position on epidemiologic issues and effectively represents it to external stakeholders, including regulatory authorities, international bodies, and key scientific opinion leaders
- Responsible for the information provided in safety and regulatory documents regarding epidemiological data
- Review in-house publications
- Lead the design & conduct of epidemiological studies/projects in collaboration with clinical ops
- Plan and coordinate scientific dissemination of epidemiological data, in consultation with internal & externsal stakeholders
- Work effectively with the clinical development & access team to communicate about disease occurrence, disease understanding, payer evidence, risk management plan, and safety issues based on reviews of available literature and/or new studies
- Contribute to the communications effort to support a product or a relevant therapeutic area, including internal presentations and papers, scientific presentations, and interactions with Advisory Boards, academic experts, and regulatory authorities
- MD or PharmD with Master’s Degree (MS or MPH) or equivalent postgraduate qualification in Epidemiology Or PhD Epidemiologist in infectious diseases and/ or vaccine-related epidemiology.
- Ideally at least 5 years of successful experience in project management of epidemiological studies at major pharmaceutical companies
- Excellent knowledge of the epidemiological research including post-authorization regulatory commitments (previous specific training is a plus)
- Formal training in infectious disease epidemiology/public health
- Formal training in vaccinology and pharmaco-epidemiology are a plus such as having experience in conducting post authorization safety study and/or impact/effectiveness studies
- Having experience in preparation and implementation of epidemiological projects in Africa is needed
- Having experience in writing protocols, driving epidemiological studies, interpretation of complex data, and presentation at scientific congresses and writing scientific papers is needed
- Training in the principles of epidemiologic study design, conduct, and quantitative analytical methods used for epidemiological studies
- Strong skills in international health with the ability to effectively work on projects implemented in developing countries
- Skills and ability to review the statistical and epidemiological literature to identify appropriate methodology to achieve research goals
- Self-motivated with the ability to effectively work independently and in a team, and to develop credibility with colleagues within and outside
- Global Epidemiology Ability to resolve problems through resourceful use of information and contacts
- Able to understand and interpret scientific methods and information and communicate the data to both scientific and lay audiences, in written and presentation formats
- Strong skills in using statistical tools and database software, as well as proficiency in collating and analyzing epidemiologic data
- Excellent communication skills, both oral and written.
- Problem-solver; ability to see solutions to complex, unique situations where the epidemiological principles need to be applied Ability to handle a high degree of change in priority projects.
- Ability to deal calmly with complex managerial and technical issues.
- Diplomacy and cross-cultural sensitivity.
- Ability to work well within a global and matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.
- Customer oriented/ Service oriented; mature; calm under pressure
- An organizer /planner /analyzer /implementer / problem-solver with demonstrated interpersonal skills
- Team player
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices: Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo Nijverheidslaan 3, - Strombeeck Bever
Send your CV and letter to [email protected] or via http://www.keyrusbiopharmajobs.com/index.php/page/applicants/command/applyforjob/vid/5843216/bb/1
End date: 27/08/18