Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and Simulation

GSK; Durham (CA); Híbrido; USD 250.000 - 350.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Long-term incentive program

Comprehensive benefits

Descripción de la vacante

GSK is seeking an Executive Director in Oncology Clinical Pharmacology Modeling and Simulation to provide scientific leadership across drug discovery and development. The role collaborates with Research, Clinical Medical, DMPK and Regulatory teams to translate CPMS insights into trials, with on-site presence 2–3 days weekly.

Lead modeling strategy for PK/PD, PBPK, exposure–response, and population PK to support dosing and regulatory submissions, while mentoring talent and aligning with corporate

Formación

• PhD in biological/pharmaceutical sciences with 15+ years in biotech/pharma.
• Extensive experience in drug development (Nonclinical and Clinical).
• Experience managing matrix teams, external providers, and consultants.
• Hands-on PK/PD data analysis and advanced modeling (Population PK, PBPK).
• Strong regulatory knowledge (ICH/FDA/EMA) and cross-functional collaboration.

Responsabilidades

• Provide advanced technical and strategic leadership for Oncology CPMS programs.
• Manage CPMS managers/directors and optimize PK/PD modeling for development, risk, and regulatory filings.
• Collaborate on study design (rBA/BE, DDI, special populations) and development plans.
• Lead authoring of regulatory dossiers and interaction with authorities.
• Develop and implement scientifically sound modeling strategies to support trial design and dosing justification.

Conocimientos

Clinical Pharmacology

Pharmacokinetics

Pharmacodynamics

Modeling & Simulation

Oncology

PK/PD

GxP Compliance

Team Leadership

Educación

PhD in Biological/Pharmaceutical Sciences

Descripción del empleo

Executive Director, Oncology Clinical Pharmacology Modeling and Simulation

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 Oncology 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, Clinical pharmacology is responsible for strategic contributions to both drug discovery and development projects. Working in collaboration with colleagues in Research, Clinical  medical, DMPK 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 trial design, data interpretation, and aid in global harmonization of pre-clinical execution and reporting. He/she will collaborate with clinical pharmacologists and clinical and other professionals in designing program strategies, execution 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

This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, including:

• provide advanced technical, therapeutic, and product development support for programs with a focus on the Oncology portfolio.

• provide managerial support to CPMS Managers and Directors. Individuals will be accountable to provide individually, or via their direct reports, optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), Clinical Pharmacology and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds.

• 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

• lead and/or 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

• implement best practices, trends, learnings, etc from internal and external sources to further CPMS contribution to R&D pipeline

• influence, define and execute a coordinated scientific and/or technical strategy (18-24 months planning horizon). Demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy.

• Identify and develop talent, providing appropriate coaching to ensure future leadership/succession plans for the CPMS organization.

• 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.

Why you?

Basic Qualifications

• PhD biological/pharmaceutical sciences or related discipline with 15+ years of experience in a biotech/life science, pharmaceutical or related industry (an equivalent combination of experience and education may be considered).
• Extensive experience in drug development functions (e.g., Nonclinical and Clinical) is required.
• A minimum of 15 years of experience managing matrix team, external service providers (worldwide), and consultants is required.
• A minimum of 5 years of experience in managing talent/direct reports
• 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 command of applicable GxPs and standard processes.
• Demonstration of cross-functional understanding related to drug development.

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.
• Inter-personal and talent growth skills.
• Excellent writing skills and familiar with ICH/FDA/EMA guidance/guidelines
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Well versed with the latest trends in the drug development industry and relevant technology solutions.

#LI-GSK*

#Hybrid*

Skills

Animal Models, Artificial Intelligence (AI), Clinical Pharmacology, Drug Design, Drug Discovery Process, Drug Discovery Research, In Vitro Models, Medication Safety, Molecular Modeling, Oncology, Pharmacodynamics, Pharmacokinetics, Pharmacometrics, Pharmacovigilance, Target Validation

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $0 to $0. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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