Janssen R&D, a member of Johnson &
Johnsons Family of Companies, is recruiting for a Scientific Director – DMPK
Development Project Leader, for the Department of Drug Metabolism and
Pharmacokinetics (DMPK), located in Beerse, Belgium.
At the Janssen Pharmaceutical Companies of
Johnson & Johnson, what matters most is helping people live full and
healthy lives. We focus on treating, curing and preventing some of the most
devastating and complex diseases of our time. And we pursue the most promising
science, wherever it might be found.
Janssen Research & Development, discovers
and develops innovative medical solutions to address important unmet medical
needs in oncology, immunology, neuroscience, infectious diseases and vaccines,
cardiovascular and metabolic diseases and global public health. Please visit
http://www.janssenrnd.com for more information.
We are Janssen. Our mission drives us. Our
patients inspire us. We collaborate with the world for the health of everyone
in it. Thriving on a diverse company culture, celebrating the uniqueness of our
employees and committed to inclusion. Proud to be an equal opportunity
The Department of Drug Metabolism &
Pharmacokinetics is a critical part of the Discovery Sciences organization in
Janssen R&D and is committed to the delivery of high-quality clinical candidates
and ultimately approved therapeutic solutions for all Therapeutic Areas (TAs)
Janssen R&D is committed to. We are currently seeking an outstanding
individual to join our team as a Scientific Director – DMPK Development Project
This position will be based in Beerse,
Belgium and will report to the EU Head DMPK development project leaders.
+ As DMPK Development Project Leader you will
represent DMPK on multidisciplinary projects and are responsible for providing
scientific leadership and strategic direction (including regulatory) to
projects you are assigned to.
+ Serve as the subject matter expert for DMPK
during all stages of early and late drug development. (including submissions).
+ Collaborate closely with the functional
groups within DMPK, key stake-holders such as Clinical Pharmacology, Non-Clinical
Safety, Biology teams, Pharmaceutical Sciences and Regulatory and identify
opportunities for project impact.
+ Establish DMPK strategies that align with
program goals and meet regulatory requirements.
+ Design, interpret, and report all
preclinical DMPK-related studies
+ Effectively communicate DMPK-related data
and their relevance to multidisciplinary project teams, management, regulatory
authorities, and potential partners.
+ Take a lead position in the preclinical
review of potential in-license candidates (due diligence)
+ Ph.D. in pharmacokinetics, drug metabolism, or related discipline with a minimum of 10+ years of relevant industrial experience in the evaluation of small molecule therapeutics. Experience in other therapeutic modalities such ASO, siRNA, peptides etc. is highly appreciated.
+ Broad understanding of various DMPK relevant areas such as physicochemical properties, drug metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation and analytical sciences.
+ Understanding of PBPK/PD modelling is highly desirable.
+ A strong understanding of regulatory guidelines for DMPK packages to support drug development (from First-in-Human studies to submission)
+ Evidence of leadership in the DMPK field and a proven track record of scientific achievement & project influence, including ability to influence external scientific and regulatory practices through publication and other interactions.
+ Ability to integrate complex data from multiple sources into a rational understanding of drug disposition.
+ Ability to translate these data into project relevance as part of anticipating and/or mitigating project challenges.
+ Good negotiation and influencing skills.
+ Ability to work with sometimes conflicting priority settings to adhere to project and departmental timelines.
+ Excellent verbal and written communication skills as well as strong interpersonal skills are essential
What’s in it for you…?
+ Contributing to our mission to continue to bring transformational new
medicines to patients for a world without disease.
+ Being part of a motivated and experienced research
team in an innovative working environment
+ Through mentoring programs, e-university and on the
job training, we ensure your personal development in a global company
+ A competitive salary, on-site sport accommodations,
health/energy programs and other benefits for you and your family
+ Flexible working hours (40 h/week), no fixed
holiday planning and possibility to work at home for non-laboratory related
Janssen Pharmaceutica N.V. (7555)