Director of Oncology Clinical Science

1 week ago


San Diego, CA, United States Pfizer Full time

POSITION SUMMARY

In this role, you will take charge of leading and coordinating the development of groundbreaking studies involving novel biological and small molecules for early-stage clinical trials in Oncology, including first-in-human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE), and proof of concept (POC) studies. Collaborating closely with the Global Development Lead (GDL) and development team members, you will execute the early oncology clinical development plans effectively.

Your responsibilities will include guiding clinical protocol development and contributing as an active member of clinical teams alongside Pfizer's development operations. You will ensure that study enrollment and delivery timelines are met while integrating the expertise of various functional disciplines such as Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine.

POSITION RESPONSIBILITIES

  • Collaborate closely with the Global Development Lead (GDL) to implement the clinical development strategy for assigned molecules and indications.

  • Provide scientific leadership in clinical studies, ensuring innovative study designs, quality trial execution, effective safety assessments, and thorough interpretation of clinical study outcomes.

  • Drive the execution of all FIH programs through to proof of concept.

  • Establish and implement the clinical data review strategy, guaranteeing data quality, analyzing emerging clinical data, and presenting significant findings to internal and external stakeholders.

  • Work with the GDL, Clinical Safety, and Biostatistics teams to analyze and interpret clinical trial data.

  • Act as a technical resource for addressing clinical issues raised by collaborators and investigators.

  • Contribute to the development of publications, abstracts, and presentations.

  • Participate in project teams to support clinical development milestones, ensuring timely startup and execution of ESoE and POC trials.

  • Lead the preparation of clinical protocols, clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documentation.

  • Foster a transparent environment that builds strong partnerships and mutual trust across teams.

  • Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization.

  • Develop effective collaborations with key partners internally and externally, including project leaders, research units, and regulatory affairs.

  • Partner with Translational Oncology and Biomarker teams to incorporate biomarker strategies into programs for early efficacy signs and patient stratification.

  • Build and maintain relationships with external experts and key opinion leaders to incorporate the latest clinical insights into development plans.

  • Stay informed about scientific and clinical literature relevant to Oncology and clinical development issues.

  • Perform other related duties as assigned regarding clinical programs.

  • Support departmental initiatives and contribute to functional area priorities as requested.

MINIMUM QUALIFICATIONS / KEY SKILLS

  • PhD or PharmD with a minimum of 5 years of relevant experience in industry or CRO, OR MS with a minimum of 7 years, OR BA/BS with at least 10 years of experience.

  • Proven clinical research experience in Phase 1 Oncology studies on the sponsor side.

  • Strong understanding of Oncology Drug Development, especially in Early Development.

  • In-depth knowledge of clinical procedures, ICH guidelines, GCP, and familiarity with FDA, EMA, and global regulations.

  • Excellent scientific writing and communication skills (both written and verbal).

  • Experience in clinical document writing and complex data analysis.

  • Track record of scientific productivity as evidenced by publications, presentations, or abstracts.

  • Experience collaborating with various disciplines such as Clinical Operations, Safety, Biostatistics, and Regulatory Affairs.

  • Strong ability to build consensus and drive change across organizational levels.

  • Experience in data listing review.

  • Critical thinking skills, with a proven ability to work both collaboratively in a team-based environment and independently.

  • Experience with complex data analyses using platforms like JReview or SpotFire.

PREFERRED QUALIFICATIONS

  • Experience in a leadership role.

This position does not require medical qualification. The role demands diverse leadership capabilities, including the ability to influence peers, mentor others, and guide colleagues toward achieving impactful business outcomes.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

5-10% travel required.

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $169,700.00 to $282,900.00, with eligibility for Pfizer's Global Performance Plan and a bonus target of 20% of the base salary. Comprehensive benefits are also offered, including retirement savings contributions, paid leave, and health coverage options.

Relocation assistance may be available based on business needs and eligibility.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in employment and complies with all applicable nondiscrimination laws. Pfizer also participates in E-Verify and requires permanent work authorization in the United States.



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