Clinical Pharmacology Strategist

Vor 6 Tagen

Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH Vollzeit

Ridgeline Discovery GmbH is a biotechnology enterprise committed to advancing innovative therapies for obesity and cardiometabolic conditions.

The Senior Clinical Pharmacology Strategist will develop and implement clinical pharmacology strategies to support the development of our pipeline, collaborating with cross-functional teams to integrate pharmacokinetic, pharmacodynamic, and pharmacometrics analyses.

Responsibilities
  • Strategy Development: Develop and implement clinical pharmacology plans to support drug development programs, collaborating with cross-functional teams to integrate pharmacokinetic, pharmacodynamic, and pharmacometrics analyses.
  • Subject Matter Expertise: Serve as a clinical pharmacology subject matter expert and advisor to senior management, providing input on dosing regimens, sample size, and study endpoints.
  • PK/PD Modeling: Perform population PK/PD modeling, exposure-response analysis, and simulation to inform dose selection and study design, utilizing modeling and simulation tools to support decision-making.
  • Study Design and Protocol Development: Contribute to the design of clinical trials, including first-in-human (FIH) and PoC studies, providing input on dosing regimens, sample size, and study endpoints, and developing and reviewing clinical study protocols, statistical analytic plans, and other related documents.
  • Data Analysis and Data Interpretation: Analyze clinical PK/PD data and interpret the results to understand the pharmacological profile of the investigational drug, contributing to the preparation of Clinical Study Reports, the Investigator Brochure, and scientific publications.
  • Regulatory Submissions/Interactions: Work closely with Regulatory to provide clinical pharmacology support of regulatory documents, communications, and presentations as needed, including IND submissions and interactions with health authorities.

Qualifications

  • Ph.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related field.
  • 10+ years of relevant experience in clinical pharmacology and pharmacometrics, with 5+ years of experience within the context of drug development in the pharmaceutical or biotechnology industry.
  • Solid experience in pharmacokinetics, pharmacodynamics, drug-drug interactions, bioavailability/bioequivalence, special populations, and dose selection.
  • Experience with diverse modalities, including small molecules and monoclonal antibodies, and knowledge of respective FDA and ICH guidance.
  • Expert-level skills and expertise in PK/PD modeling and simulation activities, including NCA, population PK/PD modeling, literature meta-analyses, and exposure-response analyses.
  • Proven track-record of working in a matrix environment, involving CROs, academic partners, and external expert consultants.

Personal Qualities

  • Highly motivated self-starter with a can-do attitude and passion for working in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment.
  • Proven ability to build, maintain, and influence effective working relationships with key internal and external stakeholders.
  • Good planning skills and strength in delivering outputs on agreed timelines.
  • Able to work both independently and as part of a team.

What We Offer

  • International and Diverse Team: We are an international and diverse team with talented and passionate people.
  • Creativity and Innovation: We offer an innovative and creative environment.
  • Personal Development: We support the individual development of our employees.
  • Fun and Social Events: From time-to-time, we organise cool off-site summer and winter team events.
  • Well-Equipped Laboratories and Offices: Our well-equipped laboratories and offices are located at the Tech Park, a premier address for early-stage start-ups in Basel.
  • Commuter Benefits: We support our employees with tailored commuter benefits and offer parking facilities or a commuter contribution.
  • Flexible Working: We support flexible working as appropriate.
  • Christmas Closure: In addition to the 24 holidays per year, our offices/labs are closed between Christmas and New Year.
  • Birthday Retreat: On top of that, your birthday is your personal holiday - our employees enjoy their birthday with a day off.
  • Food and Coffee: We like get-togethers during lunch time, enjoying tasty, subsidised meals from our FELFEL food fridge, and meet up with your colleagues and grab free coffee.

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