Director Scientific & Medical Affairs
Posted on Nov 20, 2018 by Affinity Executive Search
CLINICAL EXPERIENCE IN OR OUTSIDE THE US
INFECTIOUS DISEASE TRAINING WITH CLINICAL AND/OR RESEARCH BACKGROUND.
KNOWLEDGE OF VACCINE TRIAL DESIGN AND MARKETING ISSUES.
THE IDEAL CANDIDATE WOULD BE SOMEONE RECOGNIZED BY OTHER VACCINE EXPERTS AS BEING EXPERT IN VACCINOLOGY OR A RELATED DISCIPLINE. AN ACCEPTABLE CANDIDATE WILL HAVE ACHIEVED RECOGNITION AS HIGHLY EXPERIENCED IN RELEVANT MATTERS, E.G. INFECTIOUS DISEASES, PUBLIC HEALTH, CLINICAL TRIALS, ETC.
THE APPLICANT IS EXPECTED TO DOCUMENT INCREASING RESPONSIBILITY FOR SIGNIFICANT INDEPENDENT RESEARCH, FOR LEADERSHIP OF PUBLIC HEALTH ACTIVITIES, OR FOR RELEVANT PRODUCT DEVELOPMENT, COUPLED WITH DEMONSTRATED MEDICAL LEADERSHIP CAPABILITIES.
OFFICIAL JOB DESCRIPTION BELOW:
To represent company Medical to the external professional community and to provide medical leadership and support to internal stakeholders, including Commercial Operations, Public Affairs, and many others. Execute all aspects of Medical strategies, including leading external advisory boards; provide oversight of -sponsored clinical trials (eg, phase IV post-marketing studies); support for investigator-sponsored studies; interaction with external government agencies, advisory and guidance committees, and external experts on issues related to products; and providing medical leadership to guide internal and external decision-making.
Clinical Trial Management
Design and execute -sponsored clinical trials, including Phase 4 post-marketing and observational studies, and oversee investigator-sponsored studies (ISSs).
Consistent with Life Cycle Management and Global Brand Team strategies (i.e., Integrated Evidence Generation Plans [iEGPs]), develop and execute clinical trials of our products. For -sponsored studies, develop the study design and protocol; identify potential investigators and study sites; contribute to budget plans; collaborate with the Clinical Operations team including the clinical program manager, biostatistician, medical writer, and others; and ensure timely and successful execution, analysis and reporting of the trial. Review in detail the documents that capture clinical trial data, including diary cards and case report forms, needed to successfully compile and analyze accurate and useful data. Monitor the safety of clinical trial participants by reviewing all serious and non-serious adverse events that are reported by the study sites in accordance with Good Clinical Practice (GCP) guidelines. Play a pivotal role in writing, reviewing, editing, and approving key regulatory documents for submission to the US Food and Drug Administration (FDA) and other health authorities, including the Clinical Study Report and Common Technical Document, if appropriate. Identify a publication strategy and ensure its successful execution.
Encourage key external experts to apply for support for ISSs of our products, including generation of real-world evidence, when they are aligned with Life Cycle Management and Global Brand Team strategies. Evaluate each ISS to determine whether it fits in the scope of the iEGP for a given product. Present the study to internal stakeholders and manage the relationship with the investigator. If approved, manage the contract, budget, and supply of product, and monitor the studys progress. Ensure publication of study results by the investigators and submit data to the US FDA if appropriate for enhancement of the Prescribing Information.
Successful execution of company-sponsored clinical trials and observational studies in compliance with GCP, International Conference on Harmonisation (ICH), and FDA guidelines. Analyses of data that lead to publications and enhancement of the Prescribing Information and marketing materials, if appropriate. Successful and timely submission of clinical trial data to the US FDA and other health authorities, as needed, in Clinical Study Reports and other documents. Successful completion of ISSs followed by publication of the data by external investigators and submission of data to the FDA, if appropriate.
Professional Societies and Thought Leaders
Direct interaction with key professional societies (e.g., AAP, AAFP, NFID, IAC, ACP), public health authorities (e.g., CDC, ACIP, AIM, state and local health departments), and key external experts (academic and community) to provide scientific education on disease states, epidemiology, and clinical trials of our products; support company positions; provide guidance on company products and related medical issues; and identify external opinions, perceptions, and trends. Lead external advisory boards to obtain insights relevant to unlicensed new products and to existing products.
Generate personal and professional contacts through participation in professional meetings, provision of lectures, and other appropriate interactions. Seek opportunities to be of service to said societies, agencies, and key external experts (KEEs). Organize and lead external advisory boards.
Establishment of a good relationship with agencies and thought leaders so as to enhance our corporate professional image, improve understanding and use of our products, and improve relevant decision-making.
Interact with internal and external audiences in order to provide education regarding topics relevant to the Companys mission, its products and positions. Prepare and present scientific medical information related to our existing and investigational products.
Participate in company-sponsored advisory boards and educational programs at congresses; meetings of global, national, regional or local professional medical societies; educational meetings organized by public health authorities; or other venues appropriate for a medical presentation. Face-to-face, virtual (web-based), or other digital presentations to relevant groups. Assist Global Medical Information in addressing questions from HCPs about our products.
Increased understanding of vaccinology, relevant epidemiology, and available technology to prevent diseases. Improved understanding of, and support for, Company products (licensed and investigational) and positions.
Cross-functional Engagement and Support
Provide expert medical opinion and medical leadership to internal cross-functional teams and contribute to the development and execution of strategies that benefit the Company. Provide medical leadership to the field-based Medical Science Liaison (MSL) team.
Take a leadership position to guide steps necessary to achieve medical understanding of issues as they arise. Participate in the development of appropriate management strategies consistent with the medical facts. Interact externally with key professional societies, public health authorities, and key external experts to support company positions and expedite a successful management of issues related to our products. Participate in and contribute to new product launch teams. Work with R&D and Clinical Development teams to provide medical input to the design of phase 2 and phase 3 clinical studies. Provide medical guidance to internal customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) reports to the US FDA and other health authorities (eg, Periodic Benefit-Risk Evaluation Reports [PBRERs], Development Safety Update Reports [DSURs], Risk Management Plans [RMPs], and other PV reports and plans). Actively engage with and support the MSL team: provide updates of results from clinical studies (-sponsored and ISSs); discuss pivotal publications related to our products, competitor products, and related disease topics and epidemiology; develop medical education materials for external audiences; and contribute to shared meetings with MSLs including development of medical strategy and tactical efforts.
Successful management within cross-functional teams to resolve issues to the satisfaction of the Company and enhancement of Company reputation and protection of our products and positions. Demonstration of medical leadership on cross-functional teams and contribution of medical and clinical trial data necessary for PV reports. Build a collaborative and supportive relationship with the MSL team to strengthen their ability to successfully achieve the objectives of field medical activities, including medical education and engagement with KEEs. Build a collaborative relationship with R&D and Clinical Development to provide valuable input to pre-licensure studies.
MLR (Medical, Legal, Regulatory) Review Committee
Participating in the MLR process with regard to evaluating all branded marketing promotional materials and unbranded non-promotional scientific exchange materials. Evaluate the medical quality of all materials ensuring that FDA guidelines and code of federal regulations are maintained. Understand and interpret FDA guidelines on advertising and promotion.
Review promotional and non-promotional materials to ensure accuracy and compliance with internal and external guidelines, requirements, and regulations.
Accurate, compliant, and effective promotional and non-promotional materials; and enhanced understanding by marketing departments of guidelines and acceptable strategies.
Educational Material Development
Contribute to the development of unbranded disease state and branded product-specific educational materials (eg, slide decks, publications, monographs) for presentation and engagement with internal (marketing and other groups) and external audiences (health care providers, public health, and lay public). The materials may include information related to disease processes and how our products are designed to help eliminate those diseases...... click apply for full job details
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