דרושים » רפואה ופארמה » Medical Developer

We are seeking a Clinical Operation Manager to oversee and manage the execution of clinical trials, ensuring compliance with regulatory requirements and alignment with company objectives. This role is pivotal in coordinating clinical operations, supporting global clinical trial execution, vendor management, and data integrity to facilitate successful regulatory submissions.

The Clinical Operation Manager will work closely with internal teams, CROs, regulatory bodies, and external partners to ensure that all clinical trials are conducted efficiently and in compliance with FDA and international regulations.

Key Responsibilities
In collaboration with Head of clinical operations and/or Medical Director,
responsible for comprehensive study management
Lead core team meetings for assigned studies, ensuring goals and deliverables are defined, and issues, decisions, risks, and actions are appropriately tracked
Responsible for managing project-specific vendors, including Study Committees, CRO/ARO, Core Labs, and DSMBs/CECs.
Oversee and support the development of key study documents including, but not limited t,o study protocols and related amendments, study plans and procedure manuals, project tools, training materials, Informed Consent Forms, and Clinical Study Reports.
Accountable for the conduct of clinical study following the approved project plans, budgets, SOPs, and applicable regulations
Support analysis and development of action plans for investigational sites, vendor management, non-compliance, and administrative issues

We seek a highly motivated and experienced Senior Researcher to join our dynamic team. This role is pivotal in advancing our companys collaboration with leading academic institutions and healthcare organizations globally and helping our company deliver cutting-edge insights that support business growth and B2B opportunities. The ideal candidate will contribute to the entire research lifecyclefrom study design to publication.
Responsibilities
Research Collaboration:
Work closely with universities, academic institutions, and research teams worldwide to design, execute, and manage collaborative studies focused on metabolic health and performance.
Study Design & Execution:
Develop robust study designs tailored to explore metabolic health, fitness optimization, and related areas. Oversee the execution of studies, ensuring alignment with scientific standards and ethical guidelines.
Data Analysis & Insight Generation:
Analyze study and retrospective data to extract actionable insights that advance metabolic research and support our company's product development, marketing, and B2B initiatives.
Publication & Thought Leadership:
Lead the drafting and submission of high-quality manuscripts to peer-reviewed journals.
Innovation & Product Integration:
Collaborate with cross-functional teams to translate research findings into innovative product features, user education materials, and growth strategies.
Strategic Input:
Provide strategic insights to enhance our companys position as a metabolic health research leader. Identify new research opportunities that align with business goals.
Why Join us?
Be part of a company that is redefining metabolic health through groundbreaking research and technology.
Collaborate with top-tier universities and institutions worldwide.
Work in a fast-paced, innovative environment that values curiosity, creativity, and impact.
Contribute to insights that drive global health and wellness improvements.

We are looking for an experienced Clinical MD to manage and oversee our clinical development plan and the medical aspects of advanced-stage clinical trials. In this role, the Clinical MD will address medical inquiries throughout the trial process, contribute to protocol development, and participate in ongoing trial monitoring, including preparing Clinical Study Reports (CSR).

Additionally, the Clinical MD will work closely with internal and external stakeholders to shape the clinical strategy, helping to define the optimal trial path and medical indications required for FDA approval.

Key Responsibilities
Provide medical consultation and support throughout advanced clinical trials, demonstrating a deep understanding of the clinical research process.
Contribute to developing clinical trial protocols, ensuring scientific accuracy and full regulatory compliance.
Oversee the execution of clinical studies, including process monitoring and preparation of Clinical Study Reports (CSRs) summarizing key findings.
Participate in defining the optimal types of trials and clinical indications to support a strong case for FDA approval.
Manage and support the execution of complex clinical programs, including multiple concurrent trials designed to generate comprehensive and robust data.
Supervise small-scale pharmacological studies focusing on pharmacokinetic (PK) and pharmacodynamic (PD) parameters.
Lead preparations for regulatory meetings (e.g., IND), including analysis and interpretation of preclinical pharmacology and PK/PD data.
Define clinical trial objectives and endpoints as part of the overall strategy, ensuring alignment with both medical standards and regulatory expectations.

We are looking for a nonclinical lead with a toxicology and nonclinical drug development background to join our team. The role involves managing all nonclinical studies, scientific review of study plans, regulatory document review and writing, and participation in strategic discussions.

Key Responsibilities
Management and monitoring of all non-clinical studies
Review and oversee nonclinical studies Provide expert evaluation and guidance on nonclinical study plans and reports.
Regulatory support Review regulatory documents as a nonclinical SME and contribute to regulatory writing (IB, submission documents) as needed.
Strategic input in nonclinical development Offer expert guidance on nonclinical development strategies.
Participation in team meetings provide updates on study monitoring
Expert consultation Take part in dedicated expert meetings as needed.