Senior Director Quantitative Clinical Pharmacology

Glaxosmithkline Collegeville , PA 19426

Posted 2 months ago

Site Name: USA - Pennsylvania - Upper Providence

Posted Date: Mar 3 2020

The position of Senior Director Quantitative Clinical Pharmacology represents a key opportunity for professionals with PhD, MD, PharmD or equivalent background, who have a strong track record in oncology drug development, are strongly motivated and have good understanding of the scientific, clinical, operational and regulatory aspects of oncology drug development. GSK Oncology R&D is expanding rapidly, and GSK oncology is committed to the discovery and development of new oncology therapies that leverage patient-driven science to deliver improved outcomes for more patients.

Clinical Pharmacology Modelling and Simulation (CPMS) responsibilities and accountabilities generally commence at candidate selection with preparations of first time in human trials, and continue through to filing, registration, and market expansion.

In this role you assume responsibility for a team of CPMS colleagues aligned to the Oncology therapeutic area to ensure that projects and the R&D pipeline receive optimal clinical pharmacology and pharmacometric support. In particular, you will be expected to play a critical role in driving integration of end-to-end model-informed drug development. In addition, you will be accountable to define, coordinate and defend Clinical Pharmacology Modelling & Simulation (CPMS) development strategies at senior level meetings, and provide expert input into the clinical pharmacology evidence generation and integrated evidence plans in the Oncology therapeutic area.

Main responsibilities and accountabilities also include:

  • Highly influential, define and execute a co-ordinated scientific and/or technical strategy (18-24 months planning horizon) with demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy.

  • Thorough understanding and ability to apply appropriate FDA, EMA and ICH guidelines in the design of clinical studies and drug development strategy.

  • Review and write clinical pharmacology components of all regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology contents).

  • Approval of design, analysis, interpretation, reporting and corresponding regulatory documents across a portfolio of programs that relate to clinical pharmacology and pharmacometric aspects.

  • Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology contribution to R&D pipeline.

  • Ability to inspire CPMS staff, identify talent, provide appropriate coaching to ensure future leadership for the CPMS organization.

  • Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level.

  • Represent CPMS on various internal advisory boards, companywide initiatives and/or leadership teams

  • Promote transparency and communicate R&D achievements through publications in appropriate scientific journals

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • PhD or MD with > 10 year experience in quantitative clinical pharmacology

  • Experience with managing teams and developing staff

  • Significant experience in oncology clinical pharmacology and pharmacometrics gained within the pharmaceutical industry

  • Experience working with senior stakeholders in a cross functional environment

  • Strong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Prior experience with regulatory submissions and regulatory interaction in oncology novel therapeutics such as cell-therapy and novel modalities

  • Working knowledge and good understanding of quantitative methods using in oncology drug development

  • Excellent (written and oral) communication skills

  • Project experience working in a matrix environment

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, rigour and risk, governance and control, managing ambiguity and paradox.

  • Managing individual performance.

  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.

  • Setting strategic direction and leading on-going organisational transformation.

  • Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.Managing P&L and capital allocation.

  • LI-GSK

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.

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Of Clinical Pharmacology Modeling And Simulation

Glaxosmithkline

Posted 1 week ago

VIEW JOBS 3/27/2020 12:00:00 AM 2020-06-25T00:00 Site Name: USA - Pennsylvania - Philadelphia Metro, USA - Pennsylvania - Upper Providence Posted Date: Apr 6 2020 We have an exciting opportunity at GlaxoSmithKline (GSK) for a highly innovative Quantitative Clinical Pharmacologist to join our Collegeville, PA-based team supporting antiviral disease area as part of the global department of Clinical Pharmacology Modelling & Simulation. As the Director of Clinical Pharmacology Modelling and Simulation (CPMS) you will contribute to or lead a science driven group delivering clinical pharmacology and modelling & simulation excellence to development programs. You'll have the opportunity to work on both small molecules and biologics in the antiviral Disease area. GlaxoSmithKline provides a supportive environment for scientists who are aspired to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. * Provide optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds. * Play a central role in predicting human dose range, characterising exposure-response relationship and justifying dose recommendations 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 strategy and discuss outcome of model-based approaches via interactions with 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. * Promote model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation. * A doctorate (PhD, PharmD or MD) relevant to Quantitative Clinical Pharmacology in pharmaceutical research and development. * Substantial experience in clinical pharmacokinetics, modelling/simulation and drug development to solve practical problems in pharmaceutical industry. * Proven skills in pharmacokinetic-pharmacodynamic and model based meta-analysis; verifiable proficiency in pharmacometric tools such as NONMEM, Monolix, R or SAS. * Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design. * Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results. * Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritising multiple tasks. * Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of viral diseases. Preferred Qualifications: If you have the following characteristics, it would be a plus: * Small molecules and biologics experience in the viral Disease area. * Demonstrated experience in drug development of antiviral therapeutics. 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. * Budgeting and forecasting, commercial and financial acumen. * LI-GSK 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. 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. Glaxosmithkline Collegeville PA

Senior Director Quantitative Clinical Pharmacology

Glaxosmithkline