Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modelling And Simulation

Locations: USA - Pennsylvania - Upper Providence; USA - Massachusetts Waltham; USA - North Carolina - Durham

This position requires an on-site office presence for 2-3 days per week.

We have an exciting opportunity at GSK for a highly motivated and experienced Executive Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Translational Medicine. This role focuses on delivering CPMS excellence to research and development programs, helping to accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time.

Job Purpose

The Executive Director, translational & clinical pharmacology is responsible for strategic contributions to both drug discovery and development projects. Working in collaboration with colleagues in Research Technology, DMPK, Toxicology and Clinical Pharmacology to translate and bridge findings that clinical pharmacology can implement into clinical trials. The incumbent will act as a subject matter expert, working closely with the VP, Head of Oncology Clinical Pharmacology, Modeling and Simulation and the Oncology Translational Medicine leadership to provide scientific leadership in experimental design, data interpretation, and aid in global harmonization of pre-clinical execution and reporting. You will collaborate with clinical pharmacologists and bioanalysis, DMPK professionals in designing ways of working, process optimization and communication to achieve team, department, and corporate goals.

This position requires an on-site office presence for 2-3 days per week.

Key Responsibilities

• Develop strategy and provide high level guidance to ORU and OTM management, E/MDTs and clinical teams on translational aspects of clinical pharmacology, bioanalysis for drug and biomarkers, PK/PD modeling and simulations and data analyses for all GSK Oncology drug discovery and development programs
• Oversee all translational planning aspects of nonclinical and clinical bioanalysis/biomarker analysis, bridging to clinical pharmacology, and modeling/simulation in support of development programs
• Collaborate to identify and propose initial design for clinical pharmacology studies (e.g., rBA/BE, DDI, special population, human ADME, and TQT etc.) needed to support clinical development plans, risk assessment, and collaborate with research and development teams
• Input on development of efficient and effective modeling and simulation strategies, including population PK, exposure-response analysis, and physiologically based PK (PBPK) to support clinical trial design, justification of dosing regimen, and provide supportive evidence of efficacy and safety for regulatory submissions
• Contribute to the authoring of relevant sections/modules of regulatory dossier (including INDs, IBs, briefing packages, or other regulatory dossier)
• Participate in meetings with regulatory authorities, as needed
• Be conversant with bioanalysis, DMPK and clinical pharmacology guidance, relevant literature and methodologies, and mitigate areas of risk
• Advise team in the analysis of data, including internally or externally contracted PK/PD data analysis and advanced modeling and simulation, from nonclinical studies
• Develop relationships with external parties and consortia (and stay current on industry trends and practices.

• Other duties as assigned.

Job Posting Closing Date: 29th of August End Of Business US.

Why You?

Basic Qualifications:

• PhD biological/pharmaceutical sciences or related discipline with at least 15 years of experience in a biotech/life science, pharmaceutical or related industry (an equivalent combination of experience and education may be considered).
• Experience and demonstrated expertise in drug discovery and development of novel oncology therapeutics.
• Extensive experience in drug development functions (e.g., Nonclinical and Clinical) is required.
• A minimum of 14 years of experience managing matrix team, external service providers (worldwide), and consultants is required.
• Hands-on experience with clinical PK and PK/PD data analysis; and expertise with advanced modeling and simulation (e.g., Population PK, PBPK).
• Prior experience of translational research and clinical pharmacology in ADCs, TCEs, small molecules and antibodies.
• Excellent writing skills and familiar with ICH/FDA/EMA guidance/guidelines.
• Excellent command of applicable GxPs and standard processes.
• Leadership and management skills, and, demonstrated qualities in this area.
• Demonstration of cross-functional understanding related to drug development.
• Well versed with the latest trends in the drug development industry and relevant technology solutions.

Preferred Qualifications:

• Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically-sound PK-PD models.
• Understanding of PK-PD principles and commonly applied models.
• Ability to translate, condense, summarize outcomes of modeling and simulation analyses into information that can be understood and invested by project teams.
• Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mechanistic PK-PD.
• Knowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areas.
• Good listener and ability to effectively interact with colleagues with a variety of backgrounds.
• Self-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary team environment.
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.
• Ability to effectively multi-task and deliver results on time.
• Good judge of risks and excellent problem-solving ability to analyze options and manage outcomes.
• Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved across disciplines.
• Excellent interpersonal skills with strong oral/written communication and presentation skills.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.