***This is a remote role but candidates based in Greater Boston area and bilingual with spoken Mandarin is highly preferred***
Job Description
- Manages the design and implementation of one or more clinicaldevelopment programs in support of an overall Product Development Plan. Oversees 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.
- Responsible for scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, publications, and other program related documents.
- Provides in-house clinical expertise with internal stakeholders. May participate in business development activities as required by program needs.
- Acts 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 the clinical studies and complying with those requirements.
- Ensures 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
- Medical Doctor (M.D.), or non-US equivalent of M.D. degree with
relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
- At least 2 years of clinical trial experience in the pharmaceutical industry. Preferred 3+ years direct experience in oncology development in MNC (multinational company).
- Strong analytical and communication skills. Ability to interact externally and internally to support a global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills. Mandarin is highly preferred.
- This role requires the incumbent to travel up to 30% of the time.
Job Type: Full-time
Pay: $180,000.00 - $280,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
Medical specialties:
Experience:
- clinical trial experience in the pharmaceutical industry: 2 years (Required)
- oncology development: 3 years (Preferred)
License/Certification:
- Medical Doctor (M.D.), or non-US equivalent (Required)
- Completion of a residency program (Preferred)
Willingness to travel:
Work Location: Remote