GSK

Director Clinical Development, Hepatology

Employer
GSK
Location
Collegeville, Pennsylvania; San Francisco, California; Waltham, Massachusetts
Salary
Competitive
Posted
October 17 2021
Ref
301105
Organization Type
Pharma
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham Posted Date: Oct 17 2021 Within our Clinical Sciences organisation, we are relentless in delivering extraordinary impact for patients, and making GSK a brilliant place to work. We're seeking a Clinical Development Director (Hepatology) to contribute to our Phase 3 development program for the treatment of cholestatic pruritus in Primary Biliary Cholangitis (PBC). In this role, you will support the Clinical Development Lead (CDL) and clinical team to develop and deliver the clinical program and integrate pivotal studies for pruritus associated with PBC as well as overall life cycle management plans. Job purpose and key responsibilities: 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 Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery Contributing to regulatory interactions including clinical trial applications, briefing documents, presentations, addressing questions and responses Contributing to the writing of the clinical study synopsis (CSP), study protocols, clinical study reports (CSR) and any subsequent study abstract and manuscript publications Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Developing and maintaining relationships with matrix counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. 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 Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches Why you? Basic Qualifications: Bachelor's degree in a science related field Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication. Robust knowledge of ICH guidelines, GCP, FDA requirements, regulatory and reimbursement data requirements in responsible area Solid understanding of needs and priorities of regulators, payers 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 Demonstrated experience integrating genetic data to inform and guide clinical protocols Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions. Preferred Qualifications: MD, PhD or PharmD degree valuable but not required Experience leading matrix teams with a strong reputation of inspiring and motivating high performance Previous experience as a Clinical science Lead (CSL) at GSK, or a similar position in another company Significant experience in Hepatology clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. Closing date for applications: 30th November 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. 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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