307 institute for clinical pharmacology & safety English-speaking jobs in Basel

Development Safety Update Report, Periodic Safety Update Report, clinical benefit-risk assessment) o ... from Medical Affairs, Clinical Science, Regulatory, Safety/PV, non-clinical/PK, Biostatistics/Data management ... strategic guidance and being the ultimate accountable for: Clinical trial design (clinical study synopsis ... Provision of required input on clinical efficacy, safety, dosing/administration, mechanism of action, ... driving and representing the clinical development strategy for the nephrology program within the Core

of cross‑functional project teams, providing medicinal chemistry expertise and guidance to biology, pharmacology ... For our portfolio company SERAC Biosciences AG, we are looking for a motivated and experienced medicinal ... At Serac, this person will help drive projects from idea to clinical candidate while working closely ... medicinal chemistry, with a proven track record of advancing drug discovery programs from target ID to clinical ... Actively contribute to Serac’s medicinal chemistry effort, advancing projects from early discovery through clinical

both clinical trial and post-marketing cases Prioritize and process safety cases in accordance with ... SAE reconciliation activities between clinical and safety databases Coordinate SUSAR notifications ... including triage, data entry, medical coding, narrative writing, quality review, and expedited reporting for ... We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our ... For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited

and amendments and review other clinical documents like safety management plan, medical monitoring plan ... trial methodology as well as regulatory and compliance requirements for clinical trials Good understanding ... Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology ... Ensure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy ... Prime Location - Our modern laboratories and offices are located in Tech Park Basel – a leading hub for

Skills Desired Clinical Research Clinical Trials Leadership Regulatory Compliance Safety Science ... senior leadership role offers a rare opportunity to lead a high-impact agenda at the heart of Patient Safety ... the role: Direct experience leading PV Centres of Excellence or global safety governance functions ... operating in matrix organisations, and influencing senior stakeholders across functions Desirable for ... Background in quality, regulatory operations, or other compliance-critical domains Closing date for

Conduct signal detection and management, contributing to safety assessments and reports for regulatory ... Familiarity with GxP standards and the clinical trial lifecycle. ... Please note that to be considered for this role you must have the right to work in this location or hold ... Review clinical protocols, study reports, Investigator Brochures (IB), and informed consent forms (ICF ... Prepare and maintain safety sections of the Company Core Data Sheet and Reference Safety Information.

Team, overseeing medical safety monitoring and contributing to PSURs, clinical overviews, and risk‑management ... activities led by Clinical Development Ensure high‑quality medical content for digital initiatives ... and national label changes, including safety‑related updates Ensure that all medical and promotional ... research, in pharma, academia, or equivalent settings Solid understanding of clinical trial methodology ... aimed at both HCPs and patients Collaboration, Safety & Compliance Build and maintain strong collaboration

Team, overseeing medical safety monitoring and contributing to PSURs, clinical overviews, and risk‐management ... activities led by Clinical Development - Ensure high‐quality medical content for digital initiatives ... , safety oversight, and regulatory requirements - Proven experience engaging Key Opinion Leaders and ... and national label changes, including safety‐related updates - Ensure that all medical and promotional ... research, in pharma, academia, or equivalent settings - Solid understanding of clinical trial methodology

Team, overseeing medical safety monitoring and contributing to PSURs, clinical overviews, and risk‑management ... activities led by Clinical Development Ensure high‑quality medical content for digital initiatives aimed ... at both HCPs and patients Collaboration, Safety & Compliance Build and maintain strong collaboration ... research, in pharma, academia, or equivalent settings Solid understanding of clinical trial methodology ... relationships with Key Opinion Leaders and scientific societies Act as a core member of the Product Safety

clinical insight into patient safety, data review, and overall study conduct.Work closely with cross‑functional ... Development is accountable for leading and supporting the clinical development strategy across the company's ... RhyGaze is an innovative, growing biotech company developing next-generation therapies for serious eye ... hands‑on biotech environment.BenefitsWhy Join UsOpportunity to help develop breakthrough therapies for ... regulatory strategy, and key program milestones, with a focus on advancing innovative gene therapy programs for

Provide clinical insight into patient safety, data review, and overall study conduct. ... The Director of Clinical Development is accountable for leading and supporting the clinical development ... RhyGaze is an innovative, growing biotech company developing next-generation therapies for serious eye ... Benefits Why Join Us Opportunity to help develop breakthrough therapies for patients with serious ... regulatory strategy, and key program milestones, with a focus on advancing innovative gene therapy programs for

across oncology programs - Collaborate with cross-functional teams to advance drug candidates toward clinical ... decisions across global research and development teams Essential Requirements - Doctor of Philosophy in Pharmacology ... If, because of a medical condition or disability, you need a reasonable accommodation for any part of ... strategy, and translating complex data into meaningful insights that accelerate life-changing therapies for ... The final level and title for this position will be determined following the completion of the candidate

Revolution Medicines is a late‑stage clinical oncology company developing novel targeted therapies for ... Provide Quality leadership for new product introductions, technology transfers, and commercial launches ... Act as the primary Quality representative for Europe, providing leadership in regional and global governance ... operational role spans GxP Quality (GMP, GDP, GCP as applicable) and serves as the key Quality representative for ... Collaborate cross‑functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical

- Draft the early clinical development plan - Act as medical lead for early clinical studies - Represent ... , draft clinical trial protocols and serve as medical leads for these trials. ... the team in relevant decision boards - Serve a primary contact for internal and external key opinion ... first-in-human (FiH) and phase 2 proof-of-concept (PoC) and dose range finding (DRF) studies in support for ... If, because of a medical condition or disability, you need a reasonable accommodation for any part of

It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic ... PD, biomarker, and clinical datasets. ... Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology ... (DMPs, CRFs, data transfer agreements/specifications, validation plans) •    Ensure data readiness for ... high-quality data transfers, and applying advanced statistical methods to generate actionable insights for

Serve as the operational study lead and primary point of accountability for clinical trial delivery, ... Responsibilities Provide strategic leadership and end-to-end operational oversight for global clinical ... This role is accountable for ensuring the successful delivery of clinical studies in alignment with corporate ... It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic ... for study execution, CRO oversight, timelines, budgets, and risk management.

for you. ... Novartis is unable to offer relocation support for this role: please only apply if this location is accessible ... If, because of a medical condition or disability, you need a reasonable accommodation for any part of ... Clinical Sciences Trial Leader) - Support clinical data review (Clinical Sciences Trial Leader) - Contribute ... A dynamic group of Clinical Trial Leaders (Clinical Scientists) who plan and execute early phase trials

A key goal is aligning these models across teams to build institute-wide standards and make it easy for ... to become a world leading research institute for the advanced study of immunological systems with a ... Ensure transparency on delivery timelines to build trust across the institute. ... The Botnar Institute of Immune Engineering is a newly founded non-profit research organization aiming ... Training & Knowledge Management: Ensure sufficient Benchling expertise across the institute by designing

Job Description Summary The Head Clinical AI Strategy - Translational Research will be responsible for ... For use cases that are endorsed, work together with clinical teams to build an actionable delivery plan ... bring forward for prioritization. ... Skills Desired Clinical Research, Clinical Trials, People Management, Program Management, Regulatory ... development AI work and enable fit-for-purpose data availability.

About the BIIEThe Botnar Institute of Immune Engineering is an independent, non‑profit research institute ... We\'re building the digital backbone of a research institute taking on some of medicine\'s hardest problems ... worldBenefitsWhat you getMentorship, room to grow, an international community and the rare opportunity to shape an institute ... In return, you will help build a new, state‑of‑the‑art infrastructure for our interim hosting at ETH ... Both belong here.The Role: Build, Connect, and Grow TogetherWe are looking for an ambitious, network‑savvy