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Early Clinical Development Clinical Epidemiology Project Lead (CEPL)

Rockville, MD
GlaxoSmithKline
Posted 06/23/2021

Site Name: USA - Maryland - Rockville Posted Date: Jul 2 2021 Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. As the Sr. Director, Clinical Epidemiology Project Lead (CEPL) in Early Clinical Development, you will have the unique opportunity to work in a transversal role across multiple early assets. In this dynamic, global role, your focus will be on discovery and early phases of development, partnering with colleagues across R&D, helping to shap the future of our pipeline. Your responsibilities: You'll be accountable for the development, execution, and oversight of Phase I or I/II clinical studies, including the integration of global considerations into strategic decisions. Working in collaboration with the Head of Clinical R&D, and the dynamic cross functional team, you will high level development plans for early assets in the vaccines pipeline, ensuring high scientific rigor and quality of design in clinical and epidemiology studies. Ensure that the protocols, reports, publications and clinical regulatory documents are of highest scientific, operational and ethical standards and are completed in time and on budget. Collaborates with Quality and Compliance to ensure high quality execution of the clinical epi plan. Accountable for the medical and human safety aspects of the clinical and epidemiology programs. Manage the team of Senior Clinical Research and Development Leads (CRDLs), CRDLs, Senior Epidemiologists, and Epidemiologists assigned to the discovery programs. Accountable for leading the clinical matrix teams and epidemiology teams that are responsible for clinical/epidemiology study activities, including protocol development, data cleaning and reconciliation, statistical analysis plans, interfaces with Primary Investigators, clinical/ epidemiology study report finalization, in compliance with Good Clinical Practice and GSK policies and procedures. Supports cross-functional partners as necessary for activities including External Expert engagement and PI selection. Serves as the Clinical or Epidemiology Sponsor Signatory for studies within the discovery program, and is accountable for the final analysis and interpretation of clinical and epidemiology trial data. Accountable for the authorship of clinical documents for regulatory submissions, and serves as the Program Clinical Expert for input into regulatory documents/meeting. Accountable to ensure publication of clinical trial and epidemiology study data according to ICJME and relevant GSK policies and guidelines. Collaborates with cross-functional partners in the Pre Clinical, Technical R&D, Regulatory Affairs, Medical Affairs, and Early Commercial to ensure effective delivery of the project according to agreed plans. Support the development and execution of external collaborations and business development activities, including the performance of due diligence reviews, as required. Ensures effective coaching and mentorship of more junior members of the clinical and epidemiology team. Core member of the Clinical Research and Development Leadership Team at the Rockville Center. Why you? Basic Qualifications: MD Leadership experience in vaccine clinical and epidemiology research. Significant experience in vaccine clinical research or epidemiology, of which at least 5 years of experience in the Industry Preferred Qualifications: Specialism in the field of pediatrics, internal medicine, infectious diseases, clinical epidemiology Extensive knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP. Prior vaccines industry experience License to practice medicine and board and/ or professional certification is an asset. Leadership Capabilities: Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape. Proven track record of managing complex programs. Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum. Excellent people and team management skills. Strategic thinking skills and achievement oriented. Able to critically analyze information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks. Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making. Executive capability with strategic planning & budget processes such as analytical thinking. Strong leadership, coalition-building and communication skills. Excellent knowledge of spoken and written English. Why GSK? GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries. For further information, please visit www.gsk.com. Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. One important focus of our Rockville Development Center is mRNA technology including self-amplifying messenger RNA. When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company. We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus. At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. Closing date for applications: 9th July 2021 *LI-GSK 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.

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