- Responsible for medical affairs of clinical studies of investigational oncology drugs;
- Contribute to clinical development strategies and regulatory strategies;
- Lead development of clinical protocols for early phase clinical studies;
- Provide direction, leadership, and coaching to the clinical department as directed by Global CMO;
- Identify areas of risk and develop risk mitigation and risk management plans;
- Maintain strong relationships with key stakeholders and partners in external collaborations (clinical research sites, universities, government agencies, not-for-profit organizations, pharma/biotech companies, etc.);
- Demonstrate a collegial, collaborative interpersonal style and the ability to implement inclusive approaches that foster consensus and engagement across diverse constituencies;
- Provide input to preclinical studies during IND preparation to ensure alignment with clinical strategy;
- Identify and understand investigational drugs’ strengths and characteristics by cooperating with other functional teams in order to translate preclinical data to clinical output;
- Pursue clinical and regulatory expertise externally to ensure protocol quality from clinical science and regulatory perspectives;
- Provide clinical expertise via interacting with other functional teams for selecting research directions or new projects.
This position has supervisory responsibilities.
Travel may be required, about 25%
Direct Report to: [Global CMO]
The employee will perform the job in an office environment.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Regular sitting for extended periods of time.
Strong MS Excel, Word, and PowerPoint skills
Strong problem-solving skills and attention to details
Required Education, Experience and Qualifications:
- MD in oncology field
- Clinical medicine and pharmacology background preferred
- Experienced in Phase I/II clinical protocol design;
- Early-stage clinical development experience in biotech and pharmaceutical industry preferred
- Stay current with NCCN guidelines and understand competitive landscape;
- Strong analytical ability in learning and dissecting the literature and results of research;
- Familiar with the basic procedure of drug development, related policies and regulations;
- Able to identify and resolve key issues.
- Attention to details, positive work attitude, strong team spirit, dependable, strong sense of urgency
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Interested parties please send your resume to
HR email:firstname.lastname@example.org, HR@innocubebio.com