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Director, Clinical Pharmacology Modeling & Simulation Oncology

Philadelphia, Pennsylvania; New York, New York; Waltham, Massachusetts; Warren, New Jersey; Philadelphia, Pennsylvania
Closing date
Oct 13, 2022

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We have an exciting director level opportunity open for an experienced clinical pharmacologist with strong pharmacometrics skills to accelerate the development of oncology therapeutics.

As the Director of Clinical Pharmacology Modelling and Simulation (CPMS) you will be part of a science driven group using quantitative clinical pharmacology approaches, as part of the model-informed drug discovery and development (MID3) paradigm, to evolve understanding of compound behavior and optimize dose across the development continuum, delivering a competitive label.

You'll have the opportunity to work on a wide diversity of therapeutic modalities including small molecules, biologics, antibody-drug-conjugates and cell therapy approaches and contribute to the design of an efficient clinical development program, robust registration package and support life cycle management of an asset in the Oncology Therapeutic area. CPMS responsibilities cover the life cycle of drug development, commencing engagement post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through well into the post marketing setting.

GlaxoSmithKline provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.

This position can be based at GSK US at the Collegeville, PA; Waltham, MA; or RTP, NC locations and can also be remote within the east coast time zone .

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Contribute, as a member of a multi-disciplinary team, to the design of an efficient quantitative clinical development program, robust registration package and support life cycle management of assets
  • Provide optimal application of clinical pharmacokinetic, pharmacodynamic, and pharmacometric principles towards efficient drug development, risk management, and registration of compounds
  • Play a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for later studies and for special populations.
  • Develop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance
  • Present the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards and regulatory agencies
  • Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
  • Advocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration, journal publication and conference presentation.
  • Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
  • Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
  • Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application
  • Innovate through working effectively with colleagues in the department and other matrix team members, including: development team leaders, statisticians, biologists, physicians and drug metabolism scientists

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Advanced training with a degree such as PhD, PharmD and MD in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field
  • 8+ years of experience in clinical pharmacology and its utility in drug development, including pharmacokinetics and pharmacometrics approaches, and model-informed drug discovery & development
  • Proficiency with one or more pharmacometric tools such as NONMEM, Monolix, WINNONLIN and R

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • 10+ years of experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacometrics approaches, and model-informed drug discovery & development
  • Ability to articulate and advocate for the use of modeling and simulation approaches to address drug development issues and questions.
  • Drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
  • Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
  • Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
  • Ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
  • In depth experience with the mechanism, endpoints, progression and treatments of diseases in oncology.

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, rigor 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.


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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

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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