Associate Director/Director, PK/PD/PMX
Company: Fusion Pharmaceuticals
Location: Somerville
Posted on: August 4, 2022
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Job Description:
Fusion Pharmaceuticals is a clinical-stage oncology company
focused on developing next-generation radiopharmaceuticals as
precision medicines. Employing a proprietary Fast-Clear linker
technology, and leveraging the Company's actinium supply and
manufacturing expertise, Fusion connects alpha particle emitting
isotopes to various targeting molecules in order to selectively
deliver the alpha emitting payloads to tumors. Fusion's lead
program, FPI-1434 targeting insulin-like growth factor 1 receptor,
is currently in a Phase 1 clinical trial. The pipeline includes
FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3)
and FPI-2059, a small molecule acquired from Ipsen, targeting
neurotensin receptor 1 (NTSR1). In addition to a robust proprietary
pipeline, Fusion has a collaboration with AstraZeneca to jointly
develop up to three novel targeted alpha therapies (TATs), the
first of which is currently in IND enabling studies, and explore up
to five combination programs between Fusion's TATs and
AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and
immuno-oncology agents. Fusion also recently entered into a
collaboration with Merck to evaluate FPI-1434 in combination with
Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors
expressing IGF-1R.The Associate Director/Director, PK/PD/PMX will
be responsible for leading efforts to analyze, interpret, and model
pharmacokinetic/pharmacodynamic, safety, efficacy, and dosimetry
data to support preclinical and clinical program teams. This role
will be highly crossfunctional in nature and will seek to
synthesize data and information from multiple sources to inform
critical decisions and influence decisions related to dose levels
and regimens, preclinical to clinical translation, and
determination of therapeutic index. Successful candidates will have
demonstrated the potential to design and execute fit-for-purpose
PK/PD analysis/modeling efforts with impact on significant
decisions and outcomes on discovery/development
teams.Responsibilities:The Associate Director/Director, PK/PD/PMX
will provide PK/PD/Pharmacometric and scientific leadership through
analysis and interpretation of PK/PD and dosimetry data in support
of preclinical, translational, and clinical studies and
programsLead efforts to translate preclinical data to the clinical
setting by integrating data from the literature and crossfunctional
colleagues to project PK/PD and safety properties of targeted alpha
therapies in humansInterpret, analyze, and model quantitative data
to support the selection of targets, molecules, dose levels or
regimens, patient populations, and development strategies for novel
radiopharmaceuticals Understand and anticipate the high-level
issues affecting the drug discovery/development process and help
derive effective solutions. Support decision-making and implement
solutions through proactive communication and collaboration on
cross-functional teams.Plan, develop and execute PK/PD strategy of
program and product team as project leaderLead and support the
preparation and delivery of relevant portions of Phase I, II, and
III study protocols, analysis plans, data interpretation, and study
reportsResponsible for preparation of relevant INDs, IBs, CTDs and
other regulatory documents for development and registration of new
drugs and line extensions across multiple geographies. This may
involve direct interaction with FDA, EMA, and PMDA, among other
regulatory agencies.Provide coaching and mentoring to other
scientists within the department and across the company as well as
interact, teach, and collaborate with the broader research
communityRepresent the group to increase visibility externally
through key publications and active leadership in key scientific
organizationsQualifications:PhD in in Computer Science,
Mathematics, Engineering, Pharmaceutical Sciences, or a degree in
another research area relevant to PK/PD/Pharmacometrics and 5 years
of industry experience. Alternatively, a BS/MS degree and 8 years
of relevant industry experience.Good technical knowledge of PK/PD
analysis and pharmacokinetic modeling and experience with PK/PD
modeling of biologicsDirect experience in modeling PK/PD data by
applying at least one of the following: population PK/PD,
physiologically based pharmacokinetic (PBPK) modeling,
target-mediated drug disposition (TMDD), or quantitative systems
pharmacology (QSP) Ability to lead PK/PD/PMX efforts across
multiple programs and modalities and to communicate the results and
implications of findings with crossfunctional program
teamsExcellent interpersonal skills that lead to successful
collaborative working relationships with key colleagues across the
organization including clinical, discovery, and
managementUnderstanding of the drug discovery and development
process and how PK/PD/PMX can inform drug discovery/development and
address key questionsDesire to carry out scientific development and
research work with a view to publishing collaborativelyStrong
customer focus with the ability to have robust discussions with
project leaders to ensure that project, scientific and resource
demands are aligned. Fusion requires all employees to be current
with their COVID vaccination requirements.All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability, or status as a protected veteran.
PDN-9672f2da-d51e-45c4-a1d8-68c9f659cf74
Keywords: Fusion Pharmaceuticals, Somerville , Associate Director/Director, PK/PD/PMX, Executive , Somerville, Massachusetts
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