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.

Hedefimiz, dünyanın en inovatif, en iyi işleyen ve güvenilir sağlık şirketlerinden biri olmaktır. Hepimizin GSK'ya benzersiz değerler kattığına ve bilgilerimizi, deneyimimizi ve tarzlarımızı birleştirdiğimizde bu etkinin inanılmaz bir boyutta olacağına inanıyoruz. Hastalar ve tüketiciler için en başarılı çalışmalarınızı yapmaya teşvik edileceğiniz bir ortam sunan GSK'ya katılın. Kendiniz olabileceğiniz, iyi hissedebileceğiniz ve gelişmeye devam edebileceğiniz bir ortam sizi bekliyor.

İş Bulma Kurumları/Acenteleri için önemli not

GSK, bu sitede yayınlanan pozisyonlar için iş bulma kurumları/acenteleri tarafından öneri kabul etmemektedir. Tüm iş bulma kurumları/acenteleri, GSK'ya herhangi bir aday önerisinde bulunmadan önce yazılı onay almak için GSK'nın ticari ve genel tedarik/insan kaynakları departmanı ile iletişim kurmalıdır. Önceden yazılı onay alınması iş bulma kurumu/acentesi ile GSK arasında herhangi bir anlaşma (sözlü veya yazılı) için bir ön koşuldur. Bu tür bir yazılı onay alınmadan iş bulma kurumu/acentesi tarafından gerçekleştirilen herhangi bir aksiyon, GSK'nın onayı veya sözleşmeye dayalı bir anlaşma olmadan yapılmış olarak kabul edilecektir. Bu vesileyle GSK bu tür aksiyonlardan doğan herhangi bir ücret veya iş bulma kurumunun/acentesinin bu sitede yayınlanan pozisyonlarla ilgili olarak yaptığı önerilerden doğan herhangi bir ücret ödemekle yükümlü olmayacaktır.