Associate Director, Preclinical & Translation Pharmacology

Fusion Pharmaceuticals US, Inc.; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An innovative clinical-stage oncology company seeks an Associate Director for Preclinical and Translational Pharmacology. This pivotal role involves leading drug metabolism and pharmacokinetics efforts, ensuring the seamless transition of oncology radio-conjugate drugs from discovery to clinical stages. The ideal candidate will possess deep expertise in preclinical pharmacology and pharmacometrics, guiding teams to optimize drug candidates and integrate vital data for regulatory submissions. Join a forward-thinking organization committed to advancing precision medicine and making a significant impact in oncology therapeutics.

Qualifications

• 5+ years of experience in preclinical DMPK and pharmacometrics analyses.
• Expertise in integrating DMPK data into development plans.
• Strong leadership and mentoring abilities.

Responsibilities

• Lead DMPK studies and optimize lead candidates for clinical trials.
• Develop pharmacometric models to support dose selection.
• Manage relationships with CROs and ensure quality data delivery.

Skills

Preclinical Pharmacology

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Pharmacometrics

Leadership

Communication Skills

Negotiation Skills

Interpersonal Skills

Strategic Thinking

Regulatory Knowledge

Education

PhD in Pharmacokinetics or related field

PharmD

Tools

Phoenix NLME

NONMEM

Monolix

R

Job description

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 Associate Director Preclinical and Translation Pharmacology will lead efforts in drug metabolism and pharmacokinetics (DMPK) and preclinical pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics analyses to support the development of novel RadioConjugate [RCs] therapeutics. This role will play a pivotal role in advancing oncology RC drugs from discovery through clinical stages. This position requires expertise in preclinical pharmacology, translational science, and a deep understanding of small molecules, peptides, monoclonal antibodies (mAbs), bispecific T-cell engagers (BiTEs), and antibody-drug conjugates (ADCs). The ideal candidate will design and execute strategies to integrate pharmacokinetics (PK), pharmacodynamics (PD), and safety and efficacy biomarker data, ensuring seamless translation of preclinical findings into clinical success. The role also includes operational responsibilities, such as managing relationships with contract research organizations (CROs) and external vendors, ensuring high-quality and timely delivery of data and relevant reports.

Responsibilities

1. Preclinical Pharmacology and DMPK Leadership
   1. Design and oversee in vitro and in vivo DMPK studies, including absorption, distribution, metabolism, and excretion (ADME) evaluations for different modalities.
   2. Optimize lead candidates by integrating PK/PD relationships, exposure-response data, and preclinical biomarker assessments.
   3. Implement preclinical PK/PD/PMX strategies to effectively translate and guide First in Human (FIH) dose selection, with a focus on integrating pharmacokinetics (PK), pharmacodynamics (PD), safety and toxicokinetic (TK), Biodistribution and efficacy studies.
2. Pharmacometrics and Translational Modeling
   1. Lead the development of NCA analysis, physiologically based PK [PBPK], mechanistic/semi mechanistic PK/PD and exposure-response models to support dose selection and Phase I clinical trial design.
   2. Use quantitative tools (e.g., population PK, PBPK, and systems pharmacology) to enhance understanding of drug behavior and therapeutic potential.
3. Cross-functional Collaboration
   1. Partner with discovery, toxicology, clinical pharmacology, and regulatory teams to ensure translational consistency across programs.
   2. Contribute to target validation and candidate selection processes by integrating DMPK data with efficacy and safety profiles.
4. Regulatory and Documentation Support
   1. Prepare and author PK/PD/DMPK and preclinical pharmacometrics sections for regulatory submissions (e.g., IND) and authoring protocols and IBs.
   2. Represent the DMPK and preclinical/translational pharmacometrics functions in regulatory meetings and discussions.
5. CRO and Vendor Management
   1. Identify, select, and manage relationships with CROs and external vendors to support preclinical and translational studies.
   2. Negotiate contracts, set study timelines, and ensure the delivery of high-quality, reproducible data.
   3. Oversee external study execution, including ADME, PK/PD, biomarker development, and efficacy studies, ensuring alignment with project goals.
   4. Monitor vendor performance and ensure compliance with regulatory and scientific standards.
6. Therapeutic Modality Expertise
   1. Provide strategic leadership for RCs across various therapeutic modalities, including small molecules, peptides, monoclonal antibodies (mAbs), bispecifics (e.g., BiTEs), and antibody-drug conjugates (ADCs).
7. Leadership and Mentorship
   1. Supervise and mentor junior scientists in DMPK and pharmacometrics.
   2. Drive innovation in preclinical translation through implementation of state-of-the-art methodologies and technologies.

Qualifications

1. PhD, PharmD, or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or a related discipline.
2. At least 5+ years of experience in preclinical DMPK and pharmacometrics analyses in the pharmaceutical/biotechnology industry.
3. Demonstrated expertise in integrating DMPK data into preclinical and clinical development plans.
4. Experience with regulatory submissions and interactions is preferred.
5. Proficiency in PK and pharmacometrics software (e.g., Phoenix NLME, NONMEM, Monolix, and R).
6. Strong understanding of PK, PD, DMPK principles, including in vitro ADME, and bioanalysis techniques.
7. Familiarity with therapeutic modalities such as small molecules, peptides, mAbs, BiTEs, and ADCs is essential.
8. Strong leadership and mentoring abilities.
9. Excellent communication, negotiation, and interpersonal skills.
10. Strategic thinker with the ability to work effectively in a fast-paced, cross-functional environment.

Key Competencies

1. Expertise in oncology drug development across small molecules and monoclonal antibodies, BiTE, and ADCs.
2. Deep understanding of translational science and biomarker strategies.
3. Proficiency in integrating preclinical pharmacology into clinical decision-making.
4. Strong operational and project management skills for CRO and vendor oversight.

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.