Senior Clinical Development Scientist

Job Title

Job Description

Job Responsibilities:

Create or analyzes clinical trial protocols and studies ensuring adherence to regulatory requirements and alignment with strategic objectives providing recommendations for protocol optimization and enhancement.

Collaborates with multidisciplinary teams to develop robust clinical development and market access strategies for New Product Introduction (NPI) projects and post-market initiatives integrating inputs from stakeholders such as Marketing/BU Claims regional/market needs Health Economics Market Access and Post Market Surveillance (PMS).

Crafts comprehensive and compliant Clinical Evaluation Reports (CERs) Clinical Study Reports (CSRs) and clinical sections of regulatory submissions employing meticulous attention to detail and adherence to regulatory standards.

Collaborates across functions to furnish stakeholders with competitive intelligence medical and scientific insights and emerging trends fostering informed decision-making and strategic planning

Delivers clinical or medical information in response to the needs of internal and external customers leveraging key partnerships to enhance communication efficacy.

Performs in-depth literature reviews and evidence synthesis to support evidence-generation processes for both New Product Introduction (NPI) and Life Cycle Management (LCM) initiatives contributing insights to inform strategic decision-making.

Acquires and applies specialized domain knowledge in technology and therapeutic areas leveraging expertise to provide valuable contributions to clinical development activities staying informed of industry trends and advancements.

Produces high-quality documentation through the proficient use of standard software tools and systems ensuring clarity accuracy and compliance with internal procedures templates and external standards regulations and guidance.

Assists in the development of Clinical Development and Market Access strategies supporting the creation and refinement of clinical protocols according to applicable standards regulations and business processes.

Evaluates clinical study data critically and documents findings within clinical study reports ensuring robust analysis interpretation and reporting of study outcomes.

Supports evidence-based decision-making through systematic clinical literature assessment providing critical insights and recommendations to drive strategy development and regulatory submissions.

Minimum required Education:
Master or PhD in medical science or clinical medicine or Biomedical or equivalent
Minimum required Experience:

Minimum for 3-5 years of relevant industry experience (e.g. Med. Device field).
Minimum 2-3 years of experience in clinical evaluation or clinical research.

Preferred Skills:

Excellent in English speaking and writing
Clinical and Medical Know-how
Regulatory Requirements & Regulation Compliance
Data Analysis & Interpretation
Scientific Literature Reviews
Stakeholder Management
Business Acumen
New Product Introduction (NPI)
Product Lifecycle Management (PLM)
Project Management
Strategy Development
Research & Analysis
Clinical Evidence Communication
Technical Presentations
Communications Development
Clinical Study Management
Data Analysis & Interpretation
Clinical Evaluation Methodologies
Clinical Evidence Generation Strategy
Medical Writing