DMPK-PD Project Leader (f/m/d)

DMPK-PD Project Leader (f/m/d) – pharmacokinetic / Gastroplus / leadership skills / PharmD / biomarkers

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified DMPK-PD Project Leader

Background:
In the Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at
speed. This position in Translational DMPK-PD and Clinical pharmacology, a chapter within the PS function, where providing the right drug at the right dose to patients safely with an efficacious benefit is the primary focus.

We closely collaborate with our therapeutic areas and functions to convert hypotheses into innovative therapeutics.

As a DMPK-PD project leader, you will use your strong leadership skills to drive the nonclinical strategies, perform DMPK evaluations of drugs to impact their design and bring forward the best clinical candidate for an indication. You will also implement modeling and simulation strategies as well as biomarker/bioanalytical strategies to bring a meaningful benefit to patients safely.

The perfect candidate:
The perfect candidate has a PharmD, or PhD in pharmaceutical sciences and holds at least 2 years of relevant experience within a pharmacokinetic-related field. Candidates should have hands-on experience with basic modeling and simulation.

Tasks & Responsibilities:

Lead drug design and optimization strategies and compound profiling for all DMPK aspects with a strong emphasis on validating target biology and translational PK/PD concepts as well as guiding medicinal chemistry efforts towards drug-like properties.
*Support early drug discovery teams to build a translational strategy for clinical evaluation of target modulation in disease by applying, biochemical, biological and pharmacological considerations relevant to PKPD relationships.
*Apply translational PK/PD concepts within assigned projects. Conduct basic M&S activities (e.g. PKPD, PBPK, prediction of human dose and dose regimen) in projects to support drug discovery and development (during LO as part of CLS package up to EIH).
*You prepare high-quality scientific assessments of non-clinical DMPK information on development compounds suitable for internal program review and regulatory submission (e.g. for IND, IB, CTA, NDA, BLA documentation).
*Ensure and facilitate transparent decision making within the teams (Chapter, project team, biomarkers and portfolio squads), guided by clear decision criteria and based on thorough data analysis.
*You nurture trustful relationships and effective collaboration with internal and external partners.

Must Haves:

PharmD, or PhD in pharmaceutical sciences, chemistry, pharmacology, bioengineering, with dedicated training in pharmacology or PBPK/PD modeling
* Minimum of 2-5 years of experience in industry setting within a pharmacokinetic-related field.
* Expertise in discovery or early characterization of PK, metabolism, distribution, DDI and PKPD attributes of small molecule drugs and a solid understanding of pharmacology and physiology are required.
* Knowledge and hands-on experience with basic modeling and simulation is particularly appreciated to expand current skill sets in the group.
* A strong desire or ability to learn Phoenix, Berkley Madonna, Gastroplus, SimCyp or other relevant modeling and simulation tools is required.
* Additional experience in other therapeutic modalities such as macrocyclic peptides, antibody-drug candidates or protein therapeutics is considered a plus.
*An excellent understanding of pharmacokinetics and pharmacodynamics as well as strong communication skills and experience in leadership.

Soft skills:
* You are accountable and clear on the outcomes you want to achieve and deliver.
* You don’t let the organizational boundaries get in the way. When you see an issue, you fix it or escalate it.
* You are inclusive and intentionally seek out diversity. You bring your authentic self to work and help others do the same. You make it a place where everyone can fully contribute and you create a trustful environment.
* You act with urgency by taking bold actions without perfect information. You recognize what you don’t know and seek advice.
* You co-create, test and iterate to bring the best ideas to life fast.

Reference Nr.: 922972SGR
Role: DMPK-PD Project Leader
Industry: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.01.2024
Duration: 12++

Deadline: 31.10.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.