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Clinical Development Director (MD) - Hepatology

Philadelphia, Pennsylvania; San Francisco, California; Waltham, Massachusetts; Collegeville, Pennsylvania
Closing date
May 22, 2022

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Health Sciences, Medicine
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Site Name: USA - Pennsylvania - Philadelphia, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Apr 21 2022 Clinical Development Director (Hepatology) sought for linerixibat, which is in Phase 3 development for the cholestatic pruritus of Primary Biliary Cholangitis (PBC). The Clinical Development Director will need to be medically qualified and 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. This role will provide you the opportunity to lead key activities to progress your career. Job purpose and key responsibilities: Providing medical oversight of clinical studies; this includes monitoring of patient safety in studies, determining patient eligibility for studies and liaising with investigators. 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 “Candidates located outside the ‘Job posting primary locations' are welcome to apply. Relocation is not expected.” Why you? Basic Qualifications: We are looking for driven professionals with these required skills to achieve our goals: MD or equivalent medical qualification (i.e. MBBS) 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 / Experience: If you have the following characteristics, it would be a plus: PhD 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 *LI-GSK Closing date for applications: 21st May 2022 Why GSK? To unite science, talent and technology to get ahead of disease together - all with the clear goal of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. It means innovating together, fusing ideas, capabilities, and know-how inside and outside of GSK. And we remain committed to getting ahead of issues that matter for the sustainability of our company, be it pricing and access, the environment, or stronger diversity and inclusion. 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 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. 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