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Director, Clinical & Quantitative Pharmacology

Company: Prelude Therapeutics
Location: Wilmington
Posted on: January 16, 2022

Job Description:

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.

Job Overview:
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 inclusion/exclusion criteria
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 projects
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 regulatory meetings
Contribute to common drug development documents including regulatory submissions such as CTDs, briefing documents, IBs, clinical study reports, etc.

Qualifications:

PhD in pharmaceutical sciences, pharmacology, or related field, or PharmD with at least 5 years' experience in clinical and quantitative pharmacology.
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 data-based decisions.
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 environment.
Oncology experience, a plus.

Special Characteristics/Job Requirements:

Physical Activities:
Walking, Feeling, Talking, Hearing and Repetitive motion.
Physical Requirements:
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.
Work Conditions:
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

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