Job Information
ERT Senior Director, Clinical Pharmacologist in Philadelphia, Pennsylvania
Reference #: R17451 At Clario, our purpose is to transform lives by unlocking better evidence. In this role, you will play a critical leadership position within our Cardiac Center of Excellence, partnering with global clients to advance earlyphase drug development through innovative clinical pharmacology and quantitative modeling expertise. You will work at the intersection of science, regulation, and strategy-helping bring lifechanging therapies to patients faster.
Primary Responsibilities
Primary preparation of statistical analysis plans and expert cardiac safety reports for clients with Clario consulting cardiologists
Provides scientific training to all staff and external consultants
Contribute to the development of a dedicated preclinical-early phase cardiac consulting service for external clients
Supports sponsor meetings (e.g. bid defense meetings, investigator meetings, kick off meetings, teleconferences) originated by project management or business development
Partner with the Sales team to provide sales support as needed.
Participate in preparation of regulatory responses and submissions, interactions with health authorities as clinical pharmacology/pharmacometrics subject matter expert (SME)
Responsible for guiding model-based efficacious dose prediction for First-In-Human studies by interpreting and integrating in vitro and in vivo data from nonclinical studies for clients.
Secondary Responsibilities
Representing Clario at scientific meetings, industry meetings, and webinars
Serve as an internal clinical pharmacology subject matter expert
Travel to client meetings or regulatory meetings may be required
Assist sales with client retention and the development of new clients.
Oversee other contract resources as assigned.
Qualifications Education:
MD, PharmD or PhD degree in life sciences (e.g., biology, biochemistry, biophysics, or pharmacology), chemical engineering, pharmacokinetics, or related disciplines
Experience:
Minimum of 8 years of experienceworking in the pharmaceutical, biotech, regulatory and/or academic setting in clinical pharmacology related applications
Minimum of 5 years of experience with an understanding of drug development, PK/PD, systems pharmacology and mathematical modeling, in particular concentration-QTc modeling
Additional Skills:
Experience with preclinical and clinical development of small molecules required
Experience with early phase clinical oncologic and/or CNS drug trials required
Experience with concentration-QTc effect modeling under the ICH E14 guidance is required
Experience with pediatric development is a plus
Demonstrated regulatory interactions (FDA/EMA etc.) as a Clin Pharm lead is a plus
Expertise with modeling software such as Phoenix system, Sym-CYP , NONMEM, R etc.
Experience with PBPK modeling is a plus
A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
Excellent verbal, presentation, and written communication skills
Demonstrated understanding of CMC, translational biomarkers, drug metabolism & transporters, pharmacokinetics and drug development
Ability to foster relationships and work well within a team and organizational structure
Demonstrated record of 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.
ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteris ic protected by law.