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.
Job Summary
The Associate Director of Clinical/Translational Pharmacology and Pharmacometrics will be a key member of the PK/PD/PMX team, responsible for designing and implementing clinical pharmacology and pharmacometrics strategies to advance radioconjugate therapies. This role combines expertise in quantitative pharmacokinetics (PK), pharmacodynamics (PD), and translational sciences to drive data-driven decisions that optimize radioconjugate drug development. This individual will leverage quantitative clinical pharmacology experience with different therapeutic modalities, including but not limited to small molecules, peptides, monoclonal antibodies (mAbs), bispecific T-cell engagers (BiTEs), and antibody-drug conjugates (ADCs). The ideal candidate will work closely with cross-functional teams, including clinical pharmacology, biostatistics, regulatory affairs, and clinical development, to support the progression of drug candidates through all phases of clinical development.
Responsibilities
Quantitative Pharmacology Strategy
o Develop and execute clinical and translational pharmacology and pharmacometrics plans, including dose selection, exposure-response analysis, and PK/PD modeling to support radioconjugate development programs.
o Develop and apply quantitative methods to optimize dose selection and treatment regimens for clinical studies for different therapeutic modalities, including but not limited to small molecules, peptides, monoclonal antibodies (mAbs), bispecific T-cell engagers (BiTEs), and antibody-drug conjugates (ADCs).
o Collaborate with cross-functional teams to integrate preclinical and clinical data for decision-making.
• Mechanistic/semi-mechanistic PK/PD Modeling and E-R Analysis
o Lead the design and analysis of PK/PD and exposure-response relationships for radioconjugate therapies.
o Utilize modeling and simulation tools to predict safe and efficacious human pharmacokinetics, dose regimens, and therapeutic windows.
• Regulatory Support
o Prepare clinical pharmacology sections for regulatory submissions (INDs, IBs, CTDs and other regulatory documents). This may involve direct interaction with FDA, EMA, and PMDA, among other regulatory agencies.
o Serve as the quantitative clinical pharmacology subject matter expert during regulatory interactions.
• Translational Science
o Work closely with preclinical research teams to ensure seamless transition from discovery to clinical development.
o Apply translational approaches to bridge preclinical PK/PD and E-R data with clinical outcomes.
• Cross-functional Collaboration
o Partner with clinical development, biomarker, safety, biostatistics, and regulatory affairs teams to align strategies and deliverables.
o Communicate complex Pharmacometrics findings to non-specialist stakeholders and contribute to regulatory submissions by drafting sections on pharmacometrics/quantitative clinical pharmacology analyses.
o Act as a thought leader within the organization, influencing strategy and innovation in radioconjugate drug development.
• Leadership and Mentorship
o Provide scientific and strategic leadership to junior pharmacologists and cross-functional team members.
o Represent the clinical pharmacology function in internal and external meetings.
• Research and Innovation:
o Keep abreast of advancements in Pharmacometrics methodologies and software tools, integrating novel approaches where appropriate.
o Contribute to scientific literature by publishing findings and presenting them at relevant forums.
Qualifications
o PhD, PharmD, or MD in pharmacology, pharmaceutical sciences, or a related field with a strong background in PBPK, system pharmacology, PK/PD, E-R modeling, and quantitative clinical pharmacology.
o Minimum of 5+ years of experience in quantitative clinical pharmacology or translational sciences within the pharmaceutical/biotechnology industry.
o Demonstrated expertise in radioconjugate therapies or oncology drug development is highly preferred.
o Proven experience with regulatory submissions and regulatory interactions.
o Proficiency and extensive hands-on experience in pharmacometrics software (e.g., NONMEM, R, Monolix, Simulx, other relevance NLME tools), with a strong understanding of PK/PD modeling principles and regulatory requirements.
o Familiarity with radiopharmaceutical properties, biodistribution, and radiation dosimetry is a plus.
o Strong problem-solving and critical-thinking abilities.
o Excellent communication and presentation skills.
o Ability to work collaboratively in a fast-paced, dynamic environment.
Key Competencies
• Expertise in radioconjugate pharmacometrics, pharmacokinetics and pharmacodynamics.
• Knowledge of regulatory guidelines for clinical pharmacology.
• Strategic thinking and ability to influence cross-functional stakeholders.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
