Job Description

Your Responsibilities:

Clinical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements.
Help identify global study sites and foster relationships with study investigators
As the primary medical monitor for assigned study(ies), be the first point of contact with sites; answer site questions about eligibility, enrollment; safety and patient management
Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues
Production of clinical documents required for the conduct of clinical studies, such as clinical protocols (and amendments as needed), informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices
Preparation of abstracts and posters for scientific meetings
Preparation of slides/ presentation at internal and external meetings, such as team meetings, Advisory Boards and Board of Director Meetings
Lead ongoing data interpretation to understand safety and efficacy profile of the investigational drug
Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
Present aspects of clinical program at Site Initiation Visits, Investigator's Meetings and scientific conferences
Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas
Assist in case report form (CRF) development and data analysis plans
Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
Perform in data cleaning and clinical study report review
Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study reference manuals
Assist in generation and update of Clinical Development Plan (CDP)
Perform all duties in keeping with the Company's core values, policies and all applicable regulations.

What is Required:

Medical Doctor (M.D.), either with Board Certification in Medical Oncology/ Hematology Oncology or Internal Medicine
10+ years of clinical development experience in the pharmaceutical or biotechnology industries with at least 2 years involvement in oncology drug development
Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
Phase IIII oncology clinical trial experience preferred.
Working knowledge of the IND/NDA process preferred.
In-depth knowledge of GCP/ICH guidelines preferred.
Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
Available for ~ 25% travel, including overnight stays.

Personal Characteristics & Cultural Fit

Strong written and verbal communication skills required.
Ability to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities.
Leadership skills including a collaborative and team-oriented approach.
Good organizational, time management and interpersonal skills.
Demonstrated excellence in management skills, with track record of successfully managing multiple projects, trials, and priorities.
Ability to work well with global, multi-disciplinary teams.

Valid through: 2/16/2021