Job Summary:

Vice President, Clinical Development (Early Oncology Development) will join a global team of professionals at Scorpion Therapeutics to provide medical oversight and monitoring of oncology clinical trials. This individual will be responsible for providing medical leadership and oversight of (2) clinical development programs, with a primary focus on early phase studies.  The candidate will also participate in research discovery interactions in helping shape the clinical strategy for emerging pipeline compounds. The successful candidate will have a thorough understanding of oncology clinical development, the clinical research process, and the regulatory environment. They will also have a good understanding of the principles of clinical trial design, clinical trial safety, pharmacokinetics, and pharmacodynamics.

Responsibilities:

• Manage and provide medical oversight and monitoring of clinical programs
• Develop, review, and assess clinical trial protocols and clinical reports
• Provide medical input on safety and efficacy decisions, and ensure compliance with regulatory requirements
• Develop medical strategy for clinical development
• Serve as a key clinical representative for external-facing interactions for the program
• Establish and cultivate relationships with key opinion leaders, including leading advisory boards
• Review and assess data from clinical trials, including safety and efficacy, and provide medical input
• Collaborate with other line functions to assess data from clinical trials including biomarkers, pharmacokinetics, and pharmacodynamics
• Lead review and assessment of medical issues related to clinical trials
• Work with other medical directors, clinical scientists, and clinical operations personnel to ensure that study objectives are met according to program timelines
• Review and provide medical input on clinical trial reports
• Review and provide medical input for the development of clinical study materials
• Participate in the review of investigator and clinical site selection
• Work with clinical operations personnel to identify and address safety and efficacy issues
• Collaborate with external clinical experts and contract-research-organizations as needed
• Participate in strategic interactions with the research discovery group on internal pipeline molecules, initial clinical development and prioritization

Qualifications:

• MD, PhD, or equivalent with a minimum of 5 years of experience in oncology clinical development
• Experience in conducting early phase oncology trials (Phase I/II)
• Experience in small molecule targeted therapeutics in oncology including breast cancer and lung cancer a plus
• Experience with medical monitoring
• Knowledge and experience in the principles of clinical trial design, clinical trial safety, pharmacokinetics, and pharmacodynamics
• Experience in the management of clinical trials and clinical data management
• Knowledge of clinical trial regulations and Good Clinical Practices (e.g., ICH GCP)
• Strong understanding of integrating pre-clinical and clinical data into decision-making
• Excellent written and verbal communication skills
• Strong problem-solving and analytical skills
• Ability to work efficiently in a multi-functional clinical program team