Medical Director

Protalix BioTherapeutics is a pharmaceutical company which specializes in producing recombinant protein drugs in

plant cells and improving their characteristics using chemical modifications.

The Medical Director leads medical aspects and the development of medical procedures and technology. Serves as company liaison with healthcare providers, KOLs, and clinical trial investigators and site teams. Designs, develops and executes clinical development strategy and plans for specific indications/projects, based on knowledge of the disease area and science so to meet business, regulatory, and disease strategy targets.

Reports to VP Clinical Development and Regulatory Affairs.

Key Responsibilities

1. Lead medical aspects of the company's product development plan.
2. Provide clinical and scientific expertise in support of key business development and marketing initiatives.
3. Provide medical, clinical, and product feedback and requirements to R&D, production, regulatory, and business teams.
4. Leads and provides medical feedback to clinical trial vendors, investigators, site teams, customers, and patients.
5. Oversees CRO medical and safety monitoring
6. Provide program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, DSUR, IMPD's, IB, briefing packages, and other.
7. Support medical writing activities as needed.
8. Keep up to date on scientific and medical progress in the area of development and actively develop and maintain relationships with outside experts.
9. Identify, establish, and maintain strong relationships with international medical key-opinion-leaders.
10. Clinical responsibility - matrix reporting to the Head of Clinical Development

• Responsible for the design of the assigned clinical trial(s)
• Lead and manage one or more clinical trials projects, from concept and protocol, site identification and qualification, to database lock, analysis, and report.

* Lead the preparation, review, and approval of key clinical documents for specific indications/projects.

• Assure adherence to GCP, SOPs study protocols, and applicable regulatory requirements.

Requirements:

• MD after residency or fellowship (PhD - an advantage, several years as a senior physician - an advantage).

* internal medicine is an advantage

• At least 5 years industry experience in clinical development
• Experience in rare or orphan diseases – an advantage.
• Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.
• Ability to work in multi-disciplinary environment
• Experienced in interactions with global health authorities (FDA, EMA, PMDA) - Advantage
• High interpersonal skills to collaborate with various professionals; internally and externally
• Detail-oriented with good organizational abilities.
• Fluent English (oral and written). Additional language is an advantage
• Ability and willingness to travel abroad if needed.
• The position is in Karmiel

* Presence on site 3 times a week