Clinical Development Manager, GSK CureVac collaboration
Site Name: Belgium-Wavre, Italy - Siena, USA - Maryland - Rockville Posted Date: Aug 23 2021 GlaxoSmithKline and CureVac recently announced a new collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. If you're energized by an opportunity to accelerate and deliver a clinical data strategy as part of a wider commitment to the mRNA space, linical Development Manager role could be an exciting opportunity to explore. Your role will be to articipate to Phase I-IV Clinical Development activities within a program or group of related programs, in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK Vaccines standard operating procedures (SOP). Key Responsibilities Participate in Clinical Development activities for a study or several studies within a specific program or group of related programs. Design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across projects. Reporting accountability to Clinical and Epidemiology Research & Development Project Lead (CEPL). Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator's Brochure and the Clinical Study Report. Analyze and interpret the results as a subject matter expert. Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial. Assure that results meet the highest standards of quality and ethical conduct. Support to Independent Data Monitoring Committee (IDMC). Completes tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience. Support where applicable the Clinical and Epidemiology Research & Development Project Lead in representing GSK Vaccines in meetings with health authorities and the scientific community, net-work with thought leaders and international agencies as needed. Serves as a scientific and management reference for the project (internally/externally) Assumes accountability for the medical/legal and human safety aspects of the clinical study. (If not an MD, assembles and transmits timely summaries of clinical safety data for review by competent medical officer). Responsibility for Data Listing review for the medical portion of data listing for individual studies, assure medical consistency within trial and across trials within program. Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals. Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with PV analyse safety and potential signals and escalate accordingly. Publishes clinical data in peer review journals and presents in external scientific meetings / congresses. Maintains and expands knowledge in medical and scientific competencies (as appropriate), vaccinology and trial methodology. Supports internal process improvement activities and initiatives. Liaise with the Regional Evidence Generation team to ensure alignment of clinical trial activities (includes but not limited to, scientific and medical issues as well as subject's safety). As a member of the Clinical Project Team, always actively participate and engage within the project matrix. Actively participate as a core member of the clinical project team and contribute to achievement of team objectives. May be delegated by Clinical and Epi Project Lead or Senior CRDL to lead the Clinical Project Team. Actively participate in preparing the clinical portion of the regulatory files and the registration process Contribute to development of clinical section of regulatory files, including labelling. Provides support to Marketing/Business Development throughout product life cycle Provide medical support to Marketing/Business Development in order to achieve Company's objectives. Show active follow-up the product-related Environment Collect scientific information and review GSK Vaccines project related documents and publications. Why you? Basic Qualifications: PhD Ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology. Previous experience in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, pharmacoepidemiology, and/or clinical vaccinology is an asset. 5 years experience working in a scientific or medical institution (if not an MD, prior experience as Principal Investigator, Medical Monitor or commensurate to Clinical Research Scientist position) Basic knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP. Working knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape. Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum. Strategic thinking skills and achievement oriented. Able to critically analyze information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks. Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences. Excellent knowledge of spoken and written English. Preferred Qualifications: MD License to practice medicine and board and/ or professional certification is an asset. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams Continuously looking for opportunities to learn, build skills and share learning both internally and externally Developing people and building a talent pipeline Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally Budgeting and forecasting, commercial and financial acumen. *LI-GSK Closing date for applicaions: 30 September 2021 If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.