Head of Clinical Affairs - Pharma / Combination Device

The Head of Clinical Affairs will lead the clinical development strategies from Phase II to Phase III trials, playing a crucial role in the FDA approval processes for an innovative botanical-based medical products. This role involves close collaboration with both internal teams and external partners, including regulatory bodies, to ensure compliance and efficacy of the clinical operations.

Job Responsibilities:

● Strategic Clinical Leadership:

○ Lead the design and execution of clinical trials, ensuring alignment with strategic objectives and regulatory requirements.

○ Serve as a primary contact for clinical development at project team meetings, regulatory agency interactions, and project committees.

○ Representation: Represent Clinical Development at the Project Team level in meetings with Project Team, Regulatory Agencies, and Data Monitoring Committees (DMC).

● Regulatory and Submission Oversight:

○ Hands-on preparation of regulatory submissions, interacting with FDA and other regulatory agencies and ensuring all clinical documentation supports product approvals and lifecycle management.

○ Provide strategic input on regulatory development plan documents for submissions and discussions with health authorities.

○ Responsibilities Include: Authoring and reviewing clinical trials protocols; reviewing of regulatory dossier (IND, CTA, etc.), and regulatory documents to support meetings with Agencies (Type C meeting, EOP2, preIND, etc.); reviewing Clinical, Study Report; providing input and reviews of clinical pharmacology, summary of clinical safety, and other sections whenever appropriate.

○ Preclinical Oversight: Responsible for the review of preclinical strategy and protocols, ensuring alignment with overall clinical development plans.

● Clinical Operations and Data Integrity:

○ Oversee clinical trials and clinical operations teams and ensure accurate data collection, analysis, and reporting.

○ Maintain oversight of clinical study protocols, amendments, and scientific validity of trials.

○ Leadership and Support: Leading and Supporting the Clinical Operations Team, providing subject matter expertise, clinical science support, and function representation.

● Vendor and CRO Management:

○ Manage contract research organizations (CROs) and other vendors to ensure compliance with clinical objectives and regulatory standards.

● Stakeholder Engagement:

○ Act as a key liaison with corporate partners, KOLs, and investors.

○ Develop and maintain relationships with external key opinion leaders.

○ Represent the company in scientific, regulatory, and business development contexts.

○ Interaction Responsibilities: Interacting with regulatory Authorities, IRB/Ethics

Committees, corporate partners, KOLs, and Investors (when required).

● Advisory and Committee Leadership:

○ Participate in the planning and management of advisory boards and other scientific committees to ensure alignment of clinical strategy with expert opinions and market needs.

● Medical Writing and Publications:

○ Lead the creation of scientific and medical publications and presentations; ensure dissemination of clinical findings through appropriate channels.

○ Contribution to Publications: Contributing to the authorship and review process for scientific publications and presentations.

● Compliance and Quality Assurance:

○ Ensure all clinical activities comply with regulatory standards and ethical guidelines.

○ Maintain rigorous quality control over the entire clinical process.

Requirements:

PhD in Healthcare, Life Sciences, or related field.

Minimum 10+ years of leadership experience in clinical operations within the pharmaceutical industry.

Experience with Combination device - Big advantage

demonstrated success in developing and driving clinical development plans to execution.

Experience with botanicals, particularly in a clinical trial context, is considered an advantage.

Exceptional leadership and communication skills, fluency in Hebrew and English

Location: Center area, Isreal (Hybrid)