About the job
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Job Title: Clinical Development Physician
Reports to: VP of Clinical Development
Job Type: Full- time
Location: Remote
Salary Range: 200K-330K. Actual salary will be based on the level of experience.
Responsibilities:
- Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan. Oversee project-related education of investigators, study site personnel, and internal study staff.
- Provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting. Review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
- Establish and approve scientific methods for the design and implementation of applicable clinical protocols, data collection systems, and final reports.
- Be responsible for scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, publications, and other program related documents.
- Provide in-house clinical expertise with internal stakeholders. May participate in business development activities as required by program needs.
- Act as a clinical leader to actively interact with key opinion leaders related to the molecule and disease area.
- Participate in appropriate regulatory discussion and activities (i.e. the filing of IND and NDA). Responsible for understanding the regulatory requirements related to clinical studies and complying with those requirements.
- Ensure adherence to the highest level of Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting clinical study.
Qualifications
- PhD, Pharm. D, or MD required.
- At least 3 years of clinical trial experience in the pharmaceutical industry. Preferred direct experience in early phase oncology development programs.
- Excellent communication skills and strong analytical acumen to support a global scientific development program and business strategy.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.
- Experience in development of clinical strategies and the design of study protocols.
- Must possess excellent oral and written English communication skills.
- This role requires the incumbent to travel up to 30% of the time.
