At Clario, our purpose is to transform lives by unlocking better evidence. As Senior Director, Clinical Pharmacology - Cardiac, you will hold a critical leadership role within our Cardiac Center of Excellence, partnering with global clients to advance earlyphase drug development through innovative clinical pharmacology and quantitative modeling expertise. This role operates at the intersection of science, regulation, and strategy, helping accelerate the development of lifechanging therapies for patients worldwide. You will collaborate closely with consulting cardiologists, internal scientific experts, and commercial teams, serving as a trusted subject matter expert for cardiac safety and clinical pharmacology across early development programs. What We Offer
Opportunity to shape and expand a growing preclinicaltoearly phase cardiac consulting capability High scientific visibility with global pharmaceutical and biotechnology clients Collaborative, sciencedriven environment within a global Cardiac Center of Excellence Leadership role with influence across scientific, regulatory, and commercial strategy.
What You'll Be Doing
Lead the preparation of statistical analysis plans and expert cardiac safety reports in collaboration with Clario consulting cardiologists Provide scientific training and mentorship to internal staff and external consultants Contribute to the development of a dedicated preclinical and earlyphase cardiac consulting service for external clients Support sponsorfacing meetings including bid defenses, investigator meetings, kickoff meetings, and scientific teleconferences Partner with Sales and Business Development to provide scientific support for client engagements Participate in regulatory submissions, responses, and interactions with health authorities as a clinical pharmacology and pharmacometrics SME Guide modelbased efficacious dose prediction for FirstInHuman studies by integrating in vitro and in vivo nonclinical data Represent Clario at scientific conferences, industry meetings, and webinars Serve as an internal clinical pharmacology subject matter expert across programs Support client retention and new client development initiatives Oversee external contract resources as assigned Travel to client or regulatory meetings as required.
What We Look For
MD, PharmD, or PhD in life sciences (e.g., pharmacology, biology, biochemistry, biophysics), chemical engineering, pharmacokinetics, or a related discipline Minimum of 8 years' experience in pharmaceutical, biotechnology, regulatory, or academic settings with clinical pharmacology applications Minimum of 5 years' experience supporting drug development with PK/PD, systems pharmacology, and mathematical modeling, including concentrationQTc modeling Demonstrated experience in preclinical and clinical development of small molecules Experience supporting earlyphase oncology and/or CNS clinical trials Proven expertise with concentrationQTc effect modeling under ICH E14 guidance Experience with pediatric development and PBPK modeling preferred Demonstrated regulatory interactions with FDA, EMA, or other authorities as a clinical pharmacology lead preferred Proficiency with modeling tools such as Phoenix, SymCYP, NONMEM, and R Strong understanding of global pharmaceutical regulations and guidelines, including ICH and GCP Excellent written, verbal, and presentation communication skills Demonstrated knowledge of CMC, translational biomarkers, drug metabolism and transporters, and pharmacokinetics Ability to build strong relationships and collaborate effectively within a matrixed organization Record of scientific publications, presentations, and participation in professional organizations
EEO Statement Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
|