Senior Principal Scientist, Oncology

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Alabama

On-site

USD 180,000 - 260,000

Full time

3 days ago

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Job summary

Lantheus seeks a scientific lead to drive oncology diagnostic development across Phase I–IV, translating clinical findings into strategic recommendations aligned with asset goals.

The role requires extensive experience in oncology clinical development, imaging modalities, and regulatory interactions, with leadership across a global, cross-functional matrix and mentoring responsibilities.

Qualifications

Advanced degree in oncology, medicine, pharmaceutical sciences or related field.
Typically 10+ years in pharma/biotech with oncology clinical development experience.
Experience with oncology diagnostics, radiopharmaceutical imaging or PET imaging.
Working knowledge of FDA/EMA/ICH regulations.
Ability to lead through influence in a global cross-functional matrix.
Strong strategic judgement and written/verbal communication skills.
Willingness to travel as required.

Responsibilities

Serve as scientific lead for oncology diagnostic development across Phase I–IV clinical studies.
Develop clinical development strategies, study concepts, endpoints and evidence-generation approaches.
Lead interpretation of study data and governance documentation for regulatory submissions.
Guide protocol interpretation, data review and issue resolution with cross-functional teams.
Support interactions with FDA, EMA and other health authorities; communicate insights to stakeholders.
Mentor clinical scientists and represent Lantheus at scientific meetings.

Job description

Serve as scientific lead for assigned oncology diagnostic development programs across Phase I-IV clinical studies
Develop clinical development strategies, clinical research plans, target product profiles, study concepts, protocols, endpoints and evidence-generation approaches
Lead scientific design and interpretation of company-sponsored oncology clinical research
Translate clinical findings into strategic recommendations aligned with asset and portfolio objectives
Identify development uncertainties, risks and decision points
Provide scientific leadership to cross-functional teams across Clinical Operations, Imaging Sciences, Biostatistics, Regulatory Affairs, Medical Affairs, Pharmacovigilance, CMC, Translational Sciences and external partners
Guide protocol interpretation, data review, analysis planning, issue resolution and governance preparation
Contribute to regulatory strategies, briefing documents, submissions and responses to health authority questions
Support interactions with FDA, EMA and other applicable authorities
Monitor scientific, clinical, competitive and regulatory developments and recommend action
Build relationships with investigators, key opinion leaders, cooperative groups, academic collaborators, CROs and external experts
Lead or contribute to abstracts, manuscripts, congress presentations, data summaries and symposia
Mentor clinical scientists and project team members
Ensure compliance with quality systems, laws, regulations, guidelines, policies and procedures
Represent Lantheus at scientific meetings and conferences
Communicate key insights to internal stakeholders

Requirements

Advanced degree (PhD, PharmD, MD or equivalent) in oncology, medicine, pharmaceutical sciences, molecular biology, imaging sciences or a related scientific discipline
Typically 10 or more years of relevant experience in pharmaceutical, biotechnology, radiopharmaceutical, diagnostic imaging or clinical research environments, including substantial oncology clinical development experience
Expertise in clinical trial design, execution, data interpretation and development strategy across multiple clinical development phases
Experience with oncology diagnostics, molecular imaging, diagnostic imaging development, radiopharmaceuticals, PET imaging or other relevant imaging modalities
Working knowledge of global clinical development regulations and industry guidelines, including FDA, EMA and ICH requirements
Sustained scientific accomplishment and recognized expertise
Ability to lead through influence in a global, cross-functional matrix
Strong strategic judgement and ability to connect study-level findings with asset and portfolio objectives
Excellent written, verbal, presentation and interpersonal communication skills
Results-oriented approach with initiative, adaptability, organization, prioritization and time-management skills
Ability to work independently with minimal supervision and travel as required
Direct experience developing oncology diagnostic agents or radiopharmaceutical imaging products from early clinical development through registration or indication expansion
Experience with PET imaging, image analysis, imaging endpoint qualification, biomarker development, precision medicine or theranostic development
Experience presenting clinical development strategy or data to governance bodies and participating in health authority interactions
External scientific network and publication record relevant to oncology, diagnostic imaging or radiopharmaceutical development
Experience mentoring clinical scientists or providing functional leadership across complex programs

Core Competencies

Demonstrates expertise in oncology clinical development, including trial design, execution, and regulatory compliance. Proven ability to lead cross-functional teams and communicate strategic insights effectively to stakeholders.

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