We are looking for a Clinical Affairs Manager to implement and oversee all activities related to clinical research and clinical studies in the company.
DiA Imaging Analysis provides AI-powered solutions to make ultrasound image analysis smarter and more accessible.
Its AI-based solutions help ultrasound users acquire the right image and analyze it automatically, allowing them to identify clinical abnormalities that are often difficult to find visually and enabling them to make better decisions based on accurate and objective data.
Your role:
Designing and managing the execution of clinical studies that demonstrate medical product safety and efficacy.
Ensuring that trials are conducted in full compliance to GCP.
Full responsibility on sites initiation, site personnel training and monitoring.
Working closely with the principal investigators and study coordinators.
Working with regulatory, development and marketing teams to create scientific publications, clinical marketing material and clinical background required for regulatory submissions.

We are currently seeking a Medical Lead (all genders), to be based in our local country organization in Petach Tikva.
ROLE OBJECTIVE

Provide medical expertise for Therapeutic Area(s)/ products of responsibility to internal stakeholders (Marketing & Sales, Market access, BD)
Collaborate with cross-functional teams to ensure effective product life cycle management, from launch strategies to lifecycle planning.
Support the LOC Medical Director in establishing the local Medical Strategy Plan and its implementation for the TA of responsibility
Support the LOC Medical Director in facilitating smooth operations in the Medical department: audit readiness, budget oversight, L&D, systems integration, design, and tracking of KPIs
Ensure the correct interpretation and communication of scientific data of products
Advocacy for patients needs and safety
Lead and manage medical advisors/MSLs in GI and NPP according to medical plan.
ACCOUNTABILITIES

Medical/Scientific Affairs

Leading the development and implementation of the Strategic Medical Plan to maximize medical performance
The successful achievement of tactical objectives and milestones outlined within the Strategic medical plan
Strong understanding of the local market and close monitoring of environmental changes and competitor activities in order to be able to fine tune planned tactics;
Directing generation and analysis of data to seek out opportunities to support recommendations for strategic direction based on demand and market dynamics;
Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate
Present the clinical evidence to internal and external stakeholders in a non-promotional way
Assess scientific accuracy and validity of non-promotion material and its compliance with standards, SOPs, and national laws
Communicate and align with Regional and Global Medical Affairs functions
Develop local strategic medical plans in line with product Life Cycle Management plans and oversee execution (including the production of local publications, planning, and conduct of local Advisory Board meetings etc.)
Establish and maintain strong relationships with Key Opinion Leaders (KOLs)
Act as communication link to authors of scientific publications about products
Provide extensive, clear and structured briefing to external presenters/speakers sponsored medical events, e.g. local Advisory Boards, doctors meetings
Identify gaps in the local clinical study program which are a hurdle for successful regulatory and/or clinical acceptance of the product and propose studies to address these issues
Provide medical expertise to LOC Regulatory Affairs/LOC Pharmacovigilance/LOC Quality Assurance/LOC Market Access
Evaluate and support local investigator initiated research proposals in alignment with global strategy and standards and SOPs
Budget responsibility for medical affairs activities related to TA/product
Other medical and scientific support duties as assigned
Provide medical training for allocated therapeutic area / products to