Description

Are you energized by an opportunity to accelerate and deliver clinical safety and compliance across multiple clinical programs? If so, this Clinical Development Manager role could be an exciting opportunity to explore.

As a Clinical Development Manager, you will participate in Phase I-IV Clinical Development and Epidemiology activities within a program or group of related programs to ensure the high quality and on-time delivery of scientific data.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Participate in Clinical Development and Epidemiology activities for a study or studies within a specific program or group of related programs.

• Design clinical trial and epidemiology study protocols, and author study reports and publications of high scientific, operational and ethical standards under the supervision of an experienced senior Clinical Research Development Lead (CRDL), senior Epidemiologist or Clinical Epidemiology Program Lead (CEPL).

• Responsible for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including Investigator's Brochure and the Study Report.

• Supervise the study conduct and serve as the accountable for the overall delivery of clinical and epidemiology trials and as a scientific and management reference for the project (internally/externally).

• Support the Senior CRDL, Senior Epidemiologist or CEPL in representing therapy area in meetings with health authorities and the scientific community where applicable.

• Assemble and transmit timely summaries of clinical safety data for review by the competent medical officer and publish clinical and epidemiology data in peer review journals and presents in external scientific meetings/congresses.

• Responsible for Data Listing review for the medical portion of data listing for individual studies and assuring medical consistency within a trial and across trials within program.

• Address scientific and medical issues related to one or more clinical/epidemiology studies paying special attention to serious adverse events and potential safety signals and ensures study results meet the highest standards of quality and ethical conduct.

• Liaise with the Regional Evidence Generation and the Local Medical Leads to ensure alignment of clinical/ epidemiology trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).

• Actively participate in preparing the clinical portion of the regulatory files and the registration process and contributes to development of clinical section of regulatory files, including labelling.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master's degree
• Direct experience with Good Clinical Practices (GCP), Good Epidemiology Practice (GEP), regulatory guidelines
• Experience overseeing the medical and human safety aspects of clinical programs

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD or Doctor of Medicine (MD)
• Experience independently conducting clinical research, critically evaluating scientific aspects of immunology
• Ability to work in matrix environment and multi-task through good planning and organization skills
• Effective ability to prioritize tasks and deliver on deadlines
• Ability to translate scientific skills in clinical research into business-driven strategies

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:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

Aviso importante a las empresas o agencias de empleo

GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.