• 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.

Supervisory Responsibility:

This position has supervisory responsibilities.

Travel:

Travel may be required, about 25%

Direct Report to: [Global CMO]

Work Environment:

The employee will perform the job in an office environment.

Physical Demands:

• 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. 

Required Technology:

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

Other Duties:

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.

Contact E-mail:

Interested parties please send your resume to

HR email:lpswhr@lepubiopharma.com, HR@innocubebio.com