Sr. Director, Early Oncology Clinical Development (Solid Tumor)
Basking Ridge, Bernards, NJ, USA

SciPro is representing a leading global pharmaceutical company dedicated to creating and supplying innovative pharmaceutical therapies. This esteemed organization's mission is to enhance standards of care and address diverse, unmet medical needs worldwide by leveraging world-class science and technology. With over a century of scientific expertise and a presence in more than 20 countries, the company and its 15,000 employees globally draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to make a meaningful difference in people's lives.

Guided by their 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” the company is primarily focused on delivering novel therapies in oncology, as well as conducting research in areas related to rare diseases and immune disorders. SciPro is currently seeking oncology physician talent to contribute to this impactful mission and join their dedicated team.

Summary

The primary responsibilities of this position include planning, designing, and conducting early development clinical studies; preparing regulatory documents for filing IND and reporting studies; and representing the Solid Tumor Oncology Clinical Development (CD) function on study and project teams. This position requires a complete understanding of clinical research for drug development, from hypothesis formulation to subject enrollment, the use of statistics, assessment of endpoints, and operational execution. The role involves working independently, interacting with study and project teams, senior management, and outside advisors and vendors.

Responsibilities:

  • Study Planning: Plans and designs studies consistently with product development and clinical development plans, embracing innovation. Conducts comprehensive literature reviews and consults with internal experts and external advisors and advisory boards, contributing to the identification and assembly of these experts and boards. Defines the desired study population by delineating subject eligibility criteria for study participation and pursues the demonstration of drug activity by selecting clinical and mechanistic endpoints. Understands and employs corollary tools such as mathematical models to maximize the study data. Acts as the clinical study leader.

  • Study Execution: Collaborates with Biostatistics, Data Management, and Data Operations for statistical support and data capturing. Works closely with Clinical Safety and Pharmacovigilance for safety endpoint definition and adverse events reporting. Partners with Translational Medicine and Clinical Pharmacology for biomarker and PK endpoints selection. Collaborates with Clinical Operations to select and establish effective communication with external vendors and contribute to study logistical conductance. Coordinates with Regulatory Affairs to align the study with health authority requirements and collaborates with Quality Assurance to ensure subject safety, privacy, and data integrity.

  • Additional Study-Related Activities: Contributes to the preparation of regulatory documents for IND filing (e.g., IND modules and ICF), collaborating with preclinical research functions (e.g., Pharmacology and Toxicology). Prepares and presents material for first-in-human committees and collaborates with Medical Writing to prepare study reports. Takes responsibility for or contributes to study medical monitoring (MDs only), in conjunction with a CRO medical monitor.

  • Additional Activities: Represents Clinical Development on study and project teams and may also act as project team leader. Presents findings and progress reports to senior management. Supports business development by evaluating in-licensing opportunities (e.g., conducting due diligence) and preparing assets for out-licensing.

Qualifications:

Successful candidates will be able to meet the qualifications below with or without reasonable accommodation.

Education Qualifications (from an accredited college or university):

  • MD or MD/PhD (or equivalent), desirable

  • Board Certified in Medical Oncology or Hematology/Oncology

Experience Qualifications:

  • 10-14 years of clinical drug development, in oncology

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