Oncology Early Stage Clinical Scientist (Director, Non-MD)

Pfizer Deutschland GmbH; Maryland; On-site; USD 130,000 - 160,000; Full time

Job summary

A leading pharmaceutical company in Maryland is seeking an Oncology Early Stage Clinical Scientist to lead and coordinate the development of oncology clinical studies. The ideal candidate will have a PhD or PharmD with at least 5 years of experience in clinical research. Responsibilities include developing clinical protocols and ensuring high quality trial execution. This role offers opportunities for collaboration and scientific leadership in a fast-paced environment.

Qualifications

• Minimum of 5 years of experience in a similar role in industry/CRO.
• Experience in or strong understanding of Oncology Drug Development.
• Track record of scientific productivity as evidenced by publications.

Responsibilities

• Lead the development of the clinical protocol.
• Conduct data review, analysis and interpretation of clinical trials data.
• Foster strong partnerships among teams.

Skills

Clinical Research experience in Phase 1 in Oncology

Strong knowledge of clinical procedures, ICH guidelines, GCP

Strong scientific writing skills

Critical thinker

Education

Relevant PhD or PharmD

MS

BA/BS

Tools

JReview

SpotFire

Job description

Oncology Early Stage Clinical Scientist (Director, Non-MD)

This position is responsible for leading and coordinating the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology.

POSITION SUMMARY

The successful candidate will work in close collaboration with the Global Development Lead (GDL) and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). They will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines.

POSITION RESPONSIBILITIES

• Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
• Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
• Support execution for all FIH programs through proof-of concept
• Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
• Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics.
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
• Support and assist in the development of publications, abstracts, and presentations
• May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
• Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials).
• Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents.
• Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas.
• 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 internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations.
• Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification.
• Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results.
• Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues.
• Perform other duties as assigned related to clinical programs.
• Support functional area priorities and contribute to or lead departmental initiatives as requested.

MINIMUM QUALIFICATIONS / KEY SKILLS

• Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR
• MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR
• BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
• Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
• Experience in or strong understanding of Oncology Drug Development especially in Early Development
• Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations.
• Strong scientific writing skills and communication skills (written and verbal)
• Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis.
• Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations.
• Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance.
• Experience building consensus and driving change across all levels of the organization including senior management.
• Data listing review experience
• Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate
• Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform

PREFERRED QUALIFICATION

• Experience leading a team

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.