Job description
Ppd’s mission is to improve health.
It starts as an idea to cureIt becomes a life savedAll in-between, it’s you!
We know that meaningful results not only require the right approach, but also the right peopleWe invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.
As an ad pharmacokineticist, you will serve as the scientific leader for pharmacokinetic disciplines throughout the organization, on large pharmacokinetic projects and/or development programsProvides pharmacokinetic strategy consultation to clients for drug development planning and oversees scientific activities of the clinical pharmacology department.
Essential functions:
Serves as lead pharmacokineticist or pharmacokinetic project lead on large pharmacokinetic projects and/or development programs.
Serves as senior reviewer on pharmacokinetic projects .
Reviews clinical pharmacology deliverables and documents related to project activities.
Provides clinical pharmacology and pharmacokinetic consultation for drug development to clients.
Mentors pharmacokineticist and staff on concepts and applications of pharmacokinetics in drug development.
Engages in staff training and professional development.
Acts as a resource for information in pharmacokinetics fields and related regulatory guidelines and requirements.
Represents the department and provides scientific expertise to a wider ppd community including business development and proposal development teams.
Provides clinical pharmacology support and leadership to global corporate initiatives.
Represents the department on ppd working groupsMay serve as spokesperson for the department to external clinical pharmacology and pharmacokinetic communities.
Develops and revises department sops and guidelines for the conduct, analysis and reporting of clinical pharmacology and pharmacokinetic trials.
Assists senior management team on departmental decision making, bid and marketing activities, recruitment, and process improvement.
Maintains expertise in pharmacokinetics and related disciplines and current trends.
Key responsibilities:
Perform modeling and simulation analysis of clinical data, translational pk/pd data and dose/exposure-response analyses to guide dosing decisions from first-in-human to registrational studies
Train/mentor/develop pkpd modelers
Participate in business development activities and prepare bids and standalone work proposals
Provide pkpd input for regulatory submissions such as briefing documents, ind, and nda
Preparation of abstracts and manuscripts for publication
Job qualification
Education and experience:
Bachelor`s degree or equivalent and related formal academic / vocational qualificationAdvanced degree highly preferred, with 10+ years of experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent combination of education, training, and experience
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the jobYears of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Experience in developing pk/pd modelers.
Drug development experience in a wide range of therapeutic areas and the ability to handle contributions to multiple clinical pharmacology programs
Enthusiasm and motivation to grow capabilities and book of business and to grow and further establish a highly recognized modeling and simulation group
Regulatory agency interactions
Knowledge, skills and abilities:
Software:
Nonmem (essential)
R (essential)
Sas (preferred)
Gastroplus or other pbpk software (preferred)
Others such as metlab, python, nlme (helpful)
Population pk/pd
Exposure / response models
Translational pk/pd models
Pediatric pk/pd models
Concentration qt analyses
Target mediated drug disposition models
Bayesian statistics
Absorption/biopharmaceutical modeling (ivive)
Physiologically based modelling
Clinical trial simulations
Modelling of proteins and small molecules
Ppd is an inclusive equal employment opportunity companyWe value all people regardless of background, experience and abilities.
Ppd values the health and well-being of our employeesWe support and encourage individuals to create a healthy and balanced environment where they can thriveBelow is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel(recruiter will provide more details).*
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Diversity statement
Ppd is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respectPpd is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
