Principal Clinical Development Scientist

Warren, NJ
April 15 2021
Organization Type
Site Name: USA - New Jersey - Warren Posted Date: Apr 15 2021 GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. As Principal Clinical Research Scientist within Consumer Healthcare, you will support the delivery of clinical development excellence of clinical studies and other clinical evidence gathering activities conducted by GSK Consumer Healthcare in line with specific category project strategies. This role will provide support to cross-functional global category and sub-category teams on clinical research, new opportunities and R&D strategies. The role will require significant interaction with a number of internal teams including; Category and Regional Medical Affairs, Clinical Operations, Statistics & Data Management as well as external groups, Clinical Research Organizations and Health Care Practitioners to help achieve company objectives and to build GSK reputation. Key Responsibilities Provide scientific and technical input to category/sub-category clinical development plans Responsible for the design, implementation, reporting, interpretation, disclosure and publication of clinical studies detailed in research programs supporting consumer With support from Category Clinical Research Directors and Senior Director Clinical Research design fit-for-purpose clinical strategies and other clinical evidence generation strategies to support the business Support publications to ensure that they are scientifically robust from a medical and scientific standpoint Implement novel research methodologies in line with ICH GCP, where appropriate, to generate clinical evidence for impactful claims in support of successful product launches, brand positioning and messaging healthcare/category products and to ensure these follow external e.g. GCP, internal Medical Governance and other internal policy requirements Responsible for contributing clinical content to regulatory submissions and other regulatory engagements for clinical research activities Work closely with the pre-clinical team to ensure pre-requisite data are available to progress clinical activities Responsible for supporting clinical/medical due diligence for external opportunities from a clinical research point of view Keep up to date with relevant therapeutic/ scientific literature and provide clinical expertise to facilitate preparation of clinical development and therapeutic strategies for all categories Collaborate and co-ordinate with other groups both internal and external to ensure that research is executed as designed, on time and within budget Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Master's degree (or equivalent) in a relevant discipline such as medical or clinical science Experience in the Pharmaceutical or healthcare industry, consumer healthcare experience being preferred Demonstrated experience and proven track record of delivering clinical development programs/clinical studies/clinical evidence gathering activities such as Real World Evidence Preferred Qualifications If you have the following characteristics, it would be a plus: PhD (or equivalent) in a relevant discipline Experience within Oral Health, Wellness, Pain relief or Respiratory health Demonstrated experience representing an organization with external stakeholders Demonstrated competent business acumen Excellent verbal and written communication skills in English Strong computer literacy including competency in Microsoft Office software 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. At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers. 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. 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