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Clinical Development Director, Gastroenterology

Waltham, Massachusetts; Collegeville, Pennsylvania
Closing date
May 15, 2022

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Health Sciences, Medicine
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Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Apr 7 2022 Clinical Development Director - Gastroenterology sought for the Gastroenterology/Hepatology group in Clinical Science. You will support the Clinical Development Lead and clinical team to plan and execute studies for GI indications, develop future Phase 2/3 clinical programs as well as overall life cycle management plans, and participate in business development assessments. This role will provide you the opportunity to lead key activities to progress your career. Job purpose and key responsibilities: Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in early and/or late phase development Ensuring alignment with and support to project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Enabling key decision points and Go/No Go criteria for the CDP Enable robust protocol design, including selection of clinical endpoints, patient populations and participant monitoring strategy. Developing and maintaining relationships with program counterparts in Commercial, Research, Discovery Medicine, Regulatory, Clinical Operations and Statistics. Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in gastroenterology and/or hepatology disease area. Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile. Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery Why you? Basic Qualifications: MD, PhD, and/or PharmD degree Experience in clinical and/or academic gastroenterology and/or significant gastroenterology drug development experience with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication. Knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area Solid understanding of needs and priorities of regulators, payors and prescribers in relevant market(s) Demonstrated experience using new learning and digital tools to create innovation in other areas Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules Understanding of integrating genetic data to inform and guide clinical protocols Proven ability to utilize statistics, and visualization techniques to interpret or analyze complex information and make correct inferences and conclusions Preferred Qualifications: Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance Closing date for applications 8 May 2022 #LI-GSK #LI-HYBRID #ClinicalSciences Why GSK? We prevent and treat disease with vaccines and specialty and general medicines. We focus on the science of the immune system, human genetics, and advanced technologies, investing in four core therapeutic areas (Infectious Disease, HIV, Oncology, and Immunology/ Respiratory) and future opportunities to impact health at scale. Our pipeline currently comprises 57 vaccines and medicines, predominantly in infectious diseases, oncology, and immune-mediated diseases. We operate by the multiplier effect of Science x Technology x Culture. This approach helps us accelerate the pace at which we develop and deliver transformational medicines, prioritising those molecules with a higher probability of success and terminating less promising programmes. It also enables us to increase our focus on specialty medicines in areas such as oncology. Key partnerships: In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world's leading consumer genetics, and research company. We will combine our scientific and medical knowledge with 23andMe's large-scale genetic resources and unique data science skills, improving the probability of R&D success. This exciting collaboration builds on GSK existing partnerships, such as the Altius Institute, which pioneers new technologies and approaches for decoding gene control; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers, and the Open Targets Consortium, which supports an open-access search engine that searches, evaluates and integrates biologic and genetic disease data. Find additional details about our approach to R&D: GSK R&D 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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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