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Job Description:

Leading expert individual contributor that works independently to own major portions of Clinical Development research projects. Requires M.D., qualifications, as well as additional training and/or board certifications relevant to area of expertise.

• Acts as an expert within a specific disease area and a high-performing physician-scientist, familiar with clinical and/or translational research involving biomarkers.
• Designs and conducts development trials, assesses clinical safety and efficacy data, and develops clinical study reports, clinical sections of INDs, Investigator Brochures, etc.
• Interprets reports, prepares oral and written results of product research, and participates in the discussion of strategies formulated within the disease areas.
• Collaborates closely with leaders from adjacent functions within Janssen Pharmaceuticals (e.g., discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists), as well as personnel from Global Clinical Operations, Global Strategic Marketing, and other support functions.
• Communicates closely with and provides indirect oversight to research groups, drug discovery teams, project clinical teams, and basic laboratory scientists.
• Establishes strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.
• Serves as the Study Responsible Physician (SRP) for several complex, local studies and is responsible for creating the medical review plan and making medical decisions to execute assigned local study from the initiation to the closing and serves as local delegate of global SRP when support is needed.
• Executes medical-related consultation for internal stakeholders to ensure unbiased data interpretation.
• May provide determination of pathology diagnosis and act as a signatory to primary and peer review pathology reports.
• Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making. Maintain compliance with all company policies and procedures.

Qualification

• MD. is mandatory, MSc. or PhD is an asset. • At least 3-year clinical practice in relevant therapeutic area/or 5-year working experience in pharmaceutical industry (especially clinical development) is preferred • Excellent English abilities of listening, speaking, reading and writing; same level of CET-6 • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. • Excellent computer proficiency e.g MS Office, SAP • Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution. Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities. • Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.