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…
Why you?Basic Qualifications:
- 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
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
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.
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.
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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.
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