Director of Oncology Early Stage Clinical Development
7 hours ago
POSITION SUMMARY
If you are passionate about advancing innovative treatments in oncology, we invite you to lead the development of exciting new biological and small molecules through early-stage clinical studies. You will collaborate closely with the Global Development Lead (GDL) and the development team to design and execute comprehensive early oncology clinical development plans. Your expertise will be crucial in crafting clinical protocols and driving clinical initiatives to meet critical enrollment and study delivery timelines.
POSITION RESPONSIBILITIES
Partner closely with the Global Development Lead (GDL) to implement clinical development strategies for assigned molecule(s) and indications.
Provide scientific leadership in executing clinical studies, ensuring high-quality trial execution and accurate safety assessments.
Support First in Human (FIH) programs through proof of concept.
Establish a clinical data review strategy to ensure data quality and facilitate analysis of emerging trends, presenting findings to key stakeholders.
Work collaboratively with GDL, Clinical Safety, and Biostatistics on data analysis and interpretation.
Serve as a technical resource for internal and external collaborators, addressing clinical inquiries and challenges.
Assist in the development of scientific publications, abstracts, and presentations.
Participate in project teams to support clinical development milestones, including start-up and delivery of early efficacy studies.
Lead the creation of clinical protocols and support essential documents like clinical development plans, INDs, and clinical study reports.
Foster a collaborative environment that builds trust and partnerships across teams.
Coordinate oncology research activities within the broader Worldwide Research and Development organization.
Develop partnerships with internal and external collaborators across various disciplines.
Collaborate with Translational Oncology and Biomarker teams to ensure integration of biomarker plans into clinical programs.
Establish and maintain relationships with key opinion leaders, regulators, and investigator networks.
Stay updated on scientific and clinical literature in relevant therapeutic areas and development issues.
Perform additional duties as assigned related to clinical programs.
Support and lead functional area initiatives as necessary.
MINIMUM QUALIFICATIONS / KEY SKILLS
PhD or PharmD with a minimum of 5 years of industry/CRO experience, or MS with 7 years, or BA/BS with 10 years.
Clinical research experience in Phase 1 Oncology studies sponsored by leading organizations.
Deep understanding of Oncology Drug Development, particularly in Early Development.
Strong knowledge of ICH guidelines, GCP, FDA, EMA, and global regulations.
Excellent scientific writing and communication skills.
Experience writing clinical documents such as protocols and clinical study reports.
Proven scientific productivity through publications, posters, and presentations.
Ability to collaborate effectively across various functions, including Clinical Operations and Regulatory Affairs.
Experience in data analysis and interpretation.
Critical thinker with the ability to work in fast-paced, team-oriented environments.
Proficiency in complex data analysis platforms, such as JReview or SpotFire.
PREFERRED QUALIFICATION
Experience leading teams.
This position does not require medical qualifications.
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 role requiring on-site work an average of 2.5 days per week.
The annual base salary for this position ranges from $169,700 to $282,900, with a bonus target of 20% of the base salary and potential eligibility for a share-based long-term incentive program. We offer comprehensive benefits, including health coverage, a 401(k) plan, and generous time off policies.
Relocation assistance may be available based on business needs.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in employment. This position requires permanent work authorization in the United States.
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