DMPK-PD Project Leader (2-year temporary position)
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
pREDs Pharmaceutical Sciences (PS) group enables discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation continuously improve the accuracy of our predictions and accelerate the development of tomorrows medicines. PS supports discovery and development across the whole value chain from target assessment to on-market and beyond.
The Opportunity
As part of the Translational DMPK-PD and Clinical Pharmacology chapter you will focus on providing the right drug at the right dose to patients safely with an efficacious benefit. You will collaborate closely with therapeutic areas to convert hypotheses into innovative medicines driving nonclinical strategies to bring forward the best clinical candidates for specific indications.
Your Impact & Responsibilities:
Strategy & Design: Lead drug design and optimization strategies and compound profiling for all Drug Metabolism and Pharmacokinetics (DMPK) aspects with a strong focus on target biology validation and translational PK/Pharmacodynamics (PD) concepts.
Translational Evaluation: Provide support to early discovery teams in the development of translational strategies for the clinical evaluation of target modulation through the application of biochemical and pharmacological considerations.
Modeling & Simulation (M&S): Execute fundamental M&S activities including PKPD Physiologically-Based Pharmacokinetics (PBPK) Drug-Drug Interaction (DDI) and human dose/regimen prediction to provide essential support for projects spanning from Lead Optimization (LO) through Entry into Human (EIH).
Regulatory Support: Prepare and deliver high-quality scientific assessments of non-clinical DMPK information for internal program reviews and external regulatory submissions (e.g. Investigational New Drug (IND) Investigators Brochure (IB) Clinical Trial Application (CTA) New Drug Application (NDA) Biologics License Application (BLA)).
Implementation: Implement biomarker and bioanalytical strategies in close collaboration with key partners to ensure both patient safety and the achievement of meaningful therapeutic benefit.
Collaboration: Facilitate transparent data-driven decision-making processes within project teams and squads while cultivating and maintaining trustful professional relationships with both internal and external stakeholders.
Please note that this position is a 2-year temporary contract.
Who you are
You hold a PharmD or PhD in Pharmaceutical Sciences Pharmacology or Bioengineering paired with over 5 years of industry experience in a pharmacokinetic-related field.
You possess deep expertise in discovery early PK characterization distribution and PKPD across various modalities backed by a solid foundation in pharmacology and physiology.
You demonstrate hands-on experience with modeling and simulation proficiency in applying Artificial Intelligence (AI) Machine Learning (ML) to DMPK strategy and a strong drive to master tools like Phoenix Berkeley Madonna GastroPlus or SimCyp.
You combine an excellent understanding of PK/PD with strong communication skills and proven leadership experience to guide complex projects.
You are accountable for defining and delivering clear outcomes possessing the ability to transcend organizational boundaries to address or escalate issues effectively.
You are an inclusive authentic leader who actively seeks diversity and fosters a high-trust environment where every team member can fully contribute
Unwavering focus collaborative teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together we can be transformative.
If you are passionate about contributing to a committed team and have the dedication to partnership and innovation Roche is the place for you!
Every role at Roche plays a part in making a difference in patients now and join us in making an impact!
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
Key Skills
- IT Experience
- Robot Programming
- PMBOK
- HVAC
- Project Leadership
- Conflict Management
- Meeting Facilitation
- Schedule Management
- Project Management
- Project Management Software
- Microsoft Project
- Leadership Experience
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
