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The PositionIn Roche´s Pharmaceutical Research and Early Development organisation (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 medicine. 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.
pRED's 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 tomorrow's medicines. PS supports discovery and development across the whole value chain from target assessment to on-market and beyond.
In the Translational PKPD and Clinical Pharmacology chapter, our purpose is to select the right drug, to deliver the right dose and dosing schedule to patients to provide a meaningful benefit through strong collaboration, strategic thinking and regulatory and scientific excellence.
The OpportunityThe Clinical Pharmacology Leader (CPL) is a key member of the development teams, responsible for developing and executing the clinical pharmacology strategy for novel therapeutics from early-stage research through to post-marketing.
This role requires a strong scientific background in Clinical Pharmacology, strategic thinking, excellent communication and leadership skills. The CPL works cross-functionally with various teams, including but not limited to discovery research & non-clinical functions, clinical science, clinical biomarker, clinical operations, biometrics & data science, and regulatory affairs, to ensure the clinical pharmacology aspects of drug development are robust and aligned with the overall project goals.
Key Responsibilities:
You lead the clinical pharmacology strategy: develop, implement and execute the clinical pharmacology plan for drug development projects, including but not limited to quantitative clinical pharmacology, dose selection, drug-drug interaction (DDI), formulation & device development and special population studies (e.g., renal impairment, hepatic impairment).
You contribute to clinical trial design (from Phase 1 to Phase 3): provide expert input on clinical trial protocols, data analysis plans, and clinical study reports. Responsible and accountable for all dedicated clinical pharmacology studies.
You act as a subject matter expert: serve as the primary clinical pharmacology representative on project teams, due diligence teams and at internal and external meetings (e.g., regulatory agency meetings).
You manage and mentor: supervise and guide scientists in a visionary manner.
You communicate findings: prepare and present clinical pharmacology data to internal and external stakeholders, including regulatory agencies and scientific conferences.
You ensure regulatory compliance: author clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs/BLAs) and respond to questions from health authorities.
You bring a PharmD, MD or PhD in Clinical Pharmacology, Pharmaceutical Sciences, or a related field.
You have at least 10 years of experience in the pharmaceutical or biotechnology industry, with a focus on Clinical Pharmacology. Experience in CVRM or Neuroscience is preferred.
You have solid expertise in PK/PD and pharmacology principles, a good understanding of drug development processes, quantitative medicine, clinical trial design, and regulatory requirements
You have a track record of strong leadership, strategic thinking, agile mindset, communication, and interpersonal skills. You can work effectively cross-culturally in a matrixed team environment
You bring a genuine interest in drug development and a commitment to bringing innovative medicines to patients.
Location: Basel or Welwyn
Who we areA healthier future drives us to innovate. Together, more than 100’000 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.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
