VP Research and Development

About Amorphical

Amorphical is a groundbreaking biotechnology company that develops and manufactures unique natural-based medicines and nutritional supplements. Amorphical aims to prevent and treat major diseases and improve quality of life. Amorphical’s leading product Amorphous Calcium Carbonate presents unique merits such as improved calcium absorption and management of the body's acidity level (pH), resulting with high therapeutic potential in vast therapeutic areas. These therapeutic areas include indications such as osteoporosis, osteoporotic fractures, and hypoparathyroidism, as well as inflammatory diseases such as COPD, Crohn's, cancer, and more.

Amorphical is conducting several clinical trials in different fields in Israel with several hospitals. In addition to this, Amorphical is in the process of approving its first drug with the FDA.

Job Description

The VP of R&D is responsible for the operational management of clinical trials, pre-clinical trials, and in-vitro studies. Primary responsibilities include the direction, planning, execution, and implementation of the various departments, whether inside or outside the company. This position requires routine interaction with key internal and external stakeholders, communicating clinical status, and troubleshooting routine inquiries. The position also requires experience with regulatory authorities such as the FDA and managing global and multicenter trials.

Responsibilities:

• Lead the studies and as such, manage internal and external stakeholders.
• Provide Clinical Operations expertise and strategic leadership in evaluating, selecting, and managing Global Contract Research Organizations (CROs) and other external vendors to ensure successful first-in-human clinical trial implementation and execution in several compounds, indications, and therapeutic areas.
• Proactively manage CRO in all aspects of study progress from planning to close-out.
• Collaborate cross functionally with the program development functions to deliver trials according to plan and in the highest quality standards.
• Contribute to developing and presenting clinical trial operational strategy and updates to senior/executive leadership.
• Oversee, manage, and ensure clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
• Contribute to global regulatory submissions (FDA, EMA, and other governing regulatory bodies)
• Develop, review, and approve Clinical Quality Documents
• Manage R&D department budgets, providing ongoing financial reporting and projections.
• Facilitate the development of clinical trial agreements and other relevant documents.
• Oversee, manage, and ensure pre-clinical trials and in vitro studies are executed per key metrics (timelines, budget, operational and quality standards)
• Contributes and/or authors the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships.
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

Requirements:

• Prior experience +5 years of active monitoring, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
• M.Sc. / Ph.D or M.D in relevant disciplines
• Strong knowledge of GCP and regulatory requirements
• Excellent written and oral English communication skills
• Good organizational abilities and attention to details
• Strong decision-making skills
• Ability to work flexible hours
• High presentation and interpersonal skills
• Computer literate
• Fluent Hebrew and English
• Strong communication and organizational skills
• Strong project management skills
• Experience with supply chain management
• Ability to flag issues in a timely manner perform issue escalation.
• Flexible and able to work in a changing environment
• Team player who can also operate independently
• Vendor/CRO and budget management skills
• Traveling may be required