Head of Pharmacometrics - Romainville, FR or Leiden, NL
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville + Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), UK (London), Germany (München), the Nordics (Denmark, Norway, Sweden, Finland, Iceland), Austria (Vienna) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for a Head of Pharmacometrics - Romainville, France or Leiden, NL
Scope of the job
As a senior Director within the Clinical Pharmacology department, you will have the responsibility and accountability for providing scientific and strategic input in implementing state of the art modelling and simulation strategies across therapeutic areas spanning inflammation and fibrosis and have impact on drug development and decision making.
Additionally, you will have the opportunity to apply quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics analysis to inform development of candidate molecules from first‐in human through approval, including post‐marketing activities
- Lead quantitative and innovative strategies well integrated within clinical pharmacology to impact model informed drug development (MIDD)
- Foster the integration of pharmacometric methodology into clinical development programs
- Lead a team that can focus on new quantitative tools/technologies for potential platform analysis, disease modelling, new PK/PD modelling approaches, driving MIDD approaches across modalities
- Provide strategic leadership and technical oversight for pharmacometrics across multiple modalities and therapeutic areas supporting Phase 1‐4 clinical development
- Develop and implementing new pharmacometrics and quantitative pharmacology approaches to drive smarter drug development for programs
- Guide dose regimen/optimization strategies in partnership with clinical pharmacology leads and other therapeutic area leads and to enable data-driven decisions
- Evaluate and applying PBPK, RWD and other quantitative tools as appropriate for clinical pharmacology decision making
- Represent the department and providing subject matter expertise on cross‐functional project teams
- Develop and maintaining collaborative working relationship with colleagues within and outside the department
- Supervise, developing and mentoring junior level scientists, both direct reports and via matrix structure in clinical pharmacology department
- Author/review/approve modelling and simulation analysis plans, outputs, interpretation and presentation of key findings to regulators and to stakeholders as needed.
- Provide technical input for pharmacometrics reports and regulatory submissions
- Develop high quality modelling and simulation strategy and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and paediatric plans
- Initiate, maintain and establish relationships and agreements with contract vendors and pharmacometrics experts and consultants
- Evaluate departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirements
- Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Understand the impact of decisions and actions on the business and consulting with colleagues and management as applicable
- Participate in and collaborating with individuals from across the business in special projects
- Develop and present training within and outside the department
- Develop and mentor pharmacometricians. May have 4 PMX scientists direct reports providing support to the disease/therapeutic area.
.Who are you?
- At least 12 years of experience and a PhD, PharmD or MD degree with emphasis in quantitative pharmacology, pharmacokinetics or related field scientific discipline
- Proven track record of extensive experience in population modelling and simulations
- Expertise with standard modelling and simulation software (Monolix, Simulix, NONMEM, R, etc) is required.
- Hands-on experience with PBPK software (Pksim/MOBI, SimCyp, Gastroplus) and applications for implementing QSP models
- Recognized as an expert in own area within the organization.
- Has extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent.
- Demonstrated excellent interpersonal and communication skills, both written and oral, and has ability to communicate complex information clearly and succinctly
- Confidence and ability to present to and influence senior leaders
- Ability to critically analyse problems and provide creative solutions
- Capable people-manager who can inspire and lead colleagues to deliver PMx goal
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!