Reference #: 384324Site Name: GSK House, Baar Onyx, Home Worker - USA, USA - Pennsylvania - Upper ProvidencePosted Date: Jan 15 2024

　　Director / Senior Director Clinical Pharmacology Lifecycle Management

　　Are you interested in a highly visible, global role that allows you to partner with senior leaders from across the organisation and lead, collaborate and influence across a dynamic internal environment while representing GSK externally? If so, this Director/Senior Director Clinical Pharmacology Lifecycle Management role is an exciting opportunity to explore.

　　Job Purpose

　　The Director / Senior Director Clinical Pharmacology Lifecycle Management will provide advanced clinical pharmacology, therapeutic and regulatory support for novel and marketed GSK products across different regions. The individual will also provide strategic support for evidence generation in General Medicine and Specialty Care, ensuring pro-active life-cycle management of the portfolio. He/she will be accountable for 1) the implementation of the submission strategy for Greater China and International (GCI) and Emerging Market (EM) countries, enabling GSK's accelerated submission strategy 2) technical and clinical expert support for RTQs from regulatory agencies and 2) identifying opportunities for implementation of quantitative clinical pharmacology principles for products in the GSK and ViiV portfolios. He/she will ensure best practices for efficient, effective label updates and filing activities

　　Key Responsibilities:

　　Responsibilities generally commence at regulatory filing and registration through product life-cycle management. Individuals will be accountable to develop, present and defend GSK position, scientific and clinical pharmacology rationale at senior level, and in regulatory interactions.Establish close collaboration with the appropriate therapeutic area lead and across the global CPMS team accountable for EU, US, Japan and China submission.Thorough understanding and ability to assess clinical context and regulatory requirements and appropriate ICH and country level guidelines when new evidence is required for marketed productsWriting and reviewing clinical pharmacology study reports and regulatory documents in support of global submission with clear focus on GCI and EM submissions.Writing and reviewing the clinical pharmacology and clinical overview modules of regulatory filings and responses such that products are efficiently approved or updated with optimum labelling.Ensuring the integration of MIDD concepts and plans into overall project and clinical development strategies. This will include the design, conduct, interpretation and reporting of clinical PK, PKPD, as well as drug-disease modelling and simulation reports.Serve as point of contact for response to regulatory questions (RTQs) involving clinical pharmacology issues.Preparation, implementation and/or review of Global Data Sheet and label updates, with special focus on dosing recommendations, special populations (paediatrics, elderly, organ impairment, ethnic groups), drug-drug interactions (DDIs), pregnancy and lactation in support of global marketed products.Maintaining an advanced knowledge of therapeutic guidelines, clinical pharmacology, drug metabolism and clinical safety (e.g. DDIs), ensuring best practice and expert support,Additional activities that are not limited to supporting life-cycle management and preparation, implementation, and/or review of model-informed evidence generationDeveloping and maintaining contact with internal and external scientific experts, scientific organisations, and appropriate industry bodies.

　　Why You?

　　Basic Qualifications:PharmD, PhD, or MD highly preferred with experience in Clinical Pharmacology.Industry experience in a Director (or Senior Director) role with experience in clinical pharmacology activities in drug development alongside having numerous regulators interactions.Good understanding an hands-on experience in modelling and simulation is greatly preferred.Demonstrated experience and proven track record of delivering clinical development programs clinical studies and generating evidence through quantitative modelling and simulation methodologies and existing data.Matrix leadership and project management experience.

　　Preferred Qualifications:Post-doctoral or clinical experience.Demonstrated business acumen and innovative thinking.Complex problem-solving skills with limited information available to make strategic decisions and interpretation.  Anticipates long-term future issues.Credibility, networking & influencing skills internally and externally.Able to work in a multicultural setting across different time zones.Why Us?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

　　Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

　　As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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(US only).

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