Director, PK/PD/PMX
Fusion Pharmaceuticals
This job is no longer accepting applications
See open jobs at Fusion Pharmaceuticals.See open jobs similar to "Director, PK/PD/PMX" Ontario Bioscience Innovation Organization .Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
The 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. The incumbent will be responsible for building a preeminent group dedicated to the modeling and simulation of radiopharmaceutical products. 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 Director, PK/PD/PMX will provide scientific leadership through analysis and interpretation of PK/PD and dosimetry data in support of preclinical, translational, and clinical studies and programs
- Lead efforts to translate preclinical data to the clinical setting by integrating data from internal and external sources project PK/PD, PBPK, and safety properties of targeted alpha therapies in humans
- Interpret, analyze, and model quantitative data to support the selection of targets, molecules, dose levels or regimens, patient populations, and development strategies for novel radiopharmaceuticals
- Using PMX, anticipate the high-level issues associated with the development radiopharmaceuticals 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, PBPK strategies of program and product team
- Lead and support the preparation and delivery of relevant portions of Phase I, II, and III study protocols, analysis plans, data interpretation, and study reports
- Responsible 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 community
- Represent the group to increase visibility externally through key publications and active leadership in key scientific organizations
Qualifications:
- PhD in in Computer Science, Mathematics, Engineering, Pharmaceutical Sciences, or a degree in another research area relevant to PK/PD/Pharmacometrics and 8+ years of industry experience. Alternatively, a BS/MS degree and 10+ years of relevant industry experience.
- Excellent technical knowledge of pharmacokinetic principles and data analysis/model building
- Direct 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 teams
- Excellent interpersonal skills that lead to successful collaborative working relationships with key colleagues across the organization including clinical, discovery, and management
- Understanding of the drug discovery and development process and how PK/PD/PMX can inform drug discovery/development and address key questions
- Desire to carry out scientific development and research work with a view to publishing collaboratively
- Strong customer focus with the ability to have robust discussions with project leaders to ensure that project, scientific and resource demands are aligned.
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.
This job is no longer accepting applications
See open jobs at Fusion Pharmaceuticals.See open jobs similar to "Director, PK/PD/PMX" Ontario Bioscience Innovation Organization .