Director, Clinical & Quantitative Pharmacology
Company: Prelude Therapeutics
Posted on: January 16, 2022
Prelude is an early-stage biotechnology company founded by
proven scientists in cancer drug development. Our research is
focused on developing highly selective and differentiated small
molecule therapeutic agents targeting novel pathways for the
treatment of cancer and rare diseases.
Prelude offers a vibrant and collegial work environment and
excellent career growth opportunities. Prelude is ideally located
within 25 minutes from the Philadelphia International Airport at
the Delaware Innovation Space, an emerging research campus in the
DuPont Experimental Station.
Join a world-class team with a passion for scientific innovation
and a commitment to developing novel therapies.
Prelude is seeking a highly skilled and motivated individual who
will represent Clinical and Quantitative Pharmacology on project
teams and lead all aspects of development related to clinical and
quantitative pharmacology including overall strategy, study design,
data analysis and interpretation. The candidate should have the
ability to identify key development questions and develop the
methods and strategies to answer those questions using quantitative
analysis. The candidate will be hands-on performing a range of PK
and exposure/response modeling and simulation tasks.
Responsibilities and Duties:
Use or develop quantitative methods, including development of
mathematical models, to frame and answer key questions related to
dose selection, disease progression, and patient population
selection or formulate and evaluate go/no-go decision criteria
Integrate and aggregate nonclinical and clinical data to optimize
overall compound development strategy and inform specific elements
of individual studies including concomitant medication use or
Represent Clinical and Quantitative Pharmacology on
cross-functional matrix teams to ensure efficient and sufficient
characterization of a compound's ADME properties
Collaborate with program teams to design PK analysis plans,
coordinate sample analysis and perform PK analyses for assigned
Design and analyze healthy volunteer and/or oversee clinical
pharmacology related sub-studies within patient based clinical
studies which evaluate key clinical pharmacology questions related
to drug interactions, dosing in special populations (ie. organ
impairment), food effect, etc
Maintain a thorough and up-to-date understanding of regulatory
guidelines related to clinical pharmacology and model-informed drug
development and represent Clinical and Quantitative Pharmacology at
Contribute to common drug development documents including
regulatory submissions such as CTDs, briefing documents, IBs,
clinical study reports, etc.
PhD in pharmaceutical sciences, pharmacology, or related field, or
PharmD with at least 5 years' experience in clinical and
Demonstrated experience performing and applying various analysis
types related to PK, PD, and/or clinical response data including
NCA, PopPK, PBPK, exposure/response, and disease progression using
common pharmacometric software including Monolix, R, Phoenix
WinNonlin, NONMEM, GastroPlus, etc.
Strong oral and written communication skills with the ability to
present simple to complex analyses to a diverse audience and drive
Understanding of, or drive and desire to learn the relevant
biology, standard of care, endpoints, and competitive landscape for
assigned develop projects.
Experience managing and working with CROs.
Ability to prioritize and multitask in a high-paced
Oncology experience, a plus.
Special Characteristics/Job Requirements:
Walking, Feeling, Talking, Hearing and Repetitive motion.
Sedentary work. Involves sitting most of the time; exerts up to 10
pounds of force occasionally to lift, carry, push, pull or
otherwise move objects, including the human body.
Visual Acuity Requirements:
The worker is required to have close visual acuity.
None. The worker is not substantially exposed to adverse
environmental conditions .
Prelude Therapeutics provides equal employment opportunities to all
employees and applicants for employment and prohibits
discrimination and harassment of any type without regard to race,
color, religion, age, sex, national origin, disability status,
genetics, protected veteran status, sexual orientation, gender
identity or expression, or any other characteristic protected by
federal, state or local laws. This policy applies to all terms and
conditions of employment, including recruiting, hiring, placement,
promotion, termination, layoff, recall, transfer, leaves of
absence, compensation and training.
Prelude Therapeutics, Inc. does not accept unsolicited resumes from
recruiters, employment agencies, or staffing firms. To conduct
business with Prelude, a Master Services Agreement (MSA) must be
executed and confirmed prior to submitting any information relating
to a potential candidate. Without a signed MSA, Prelude shall not
be responsible to any individual or entity for any payment relating
to any form of fee or compensation.
And, if a resume or candidate is submitted by a recruiter, an
employment agency, or a staffing firm without a fully executed MSA,
Prelude has the unrestricted right to pursue and hire any of those
candidate(s) without any legal or financial responsibility to the
recruiter, agency, and/or firm.
Keywords: Prelude Therapeutics, Wilmington , Director, Clinical & Quantitative Pharmacology, Executive , Wilmington, Delaware
Didn't find what you're looking for? Search again!