Johnson & Johnson Careers
Requisition ID: 1905758642W
The clinical leader is responsible for providing input, oversight and guidance on Clinical Development Programs and their execution from conception of strategy to design, implementation, execution, and submission/approval under the guidance of the Sr. Clinical Leader.
Provide medical support internally for all Clinical Development Science (CDS) - responsible project activities through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to the disease area.
Maintain knowledge of therapeutic area(s) and indications, as well as maintaining of relevant regulations and guidelines to ensure safe and ethical conduct of trials.
- Maintain knowledge of therapeutic area(s) and indications, as well as maintaining of relevant regulations and guidelines to ensure safe and ethical conduct of trials.
- Attend relevant medical conferences and therapeutic area training as needed and maintain knowledge of key publications.
- Support the assessment of new in-licensing opportunities and business development activities / due diligence evaluations.
- Contribute medical and scientific input.
- Obtaining complete understanding of all clinical data for assigned compound.
- Undertake product and therapeutic area reviews and provide evidence-based input to the study-related, strategic and regulatory documents.
- Support delivering the medical aspects of the Clinical Project Development Plan (CDP) related to the indication and executing its implementation.
- Contribute to the core medical/scientific information required in all clinical documents (e.g., protocols, statistical analysis plans, core informed consent forms, clinical study reports, investigators’ brochure, clinical components of regulatory submissions, safety related documents), and assure production of high-quality documents.
- Provide medical input on behalf of CDS to the monitoring and analysis of the safety profile of the product together with Global Drug Safety.
- Responsible for ensuring projects are adequately supported medically and prioritized to ensure timely and on-target delivery on set objectives and deliverables in line with clinical development goals.
- Interface medically with affiliates as needed to provide product and therapeutic area training and to raise global project awareness for the product, both to stimulate recruitment and prepare the ground for potential future commercialization.
- MD with clinical development experience > 8 years. Post graduate training and clinical experience in the cardiovascular and / or pulmonary area is preferred.
- Record of successful management of project teams in a matrix environment
- Proven ability to lead a team including managing career development and performance review aspects of assigned team
- Must possess intimate knowledge of clinical development and clinical trial design including a working understanding of standard statistical methodologies
- First-hand experience with handling inquiries/requests from regulatory agencies highly desirable
- Sound knowledge of regulatory requirements, International Council for Harmonisation - Good Clinical Practice (ICH-GCP) guidelines
- Fluent in English
- Good organizational skills, and able to effectively work as part of a team in a matrix environment and independently
- Motivated and energetic individual with high personal and ethical standards
- Flexible mindset, agile, and able to deliver on timelines and strict deadlines
- Demonstrated ability to think strategically
- Excellent communication skills. Strong verbal, written, and presentation skills are essential
- Detail-oriented with a hands-on approach
- Strong scientific oral and written communication skills
- Demonstrated analytical and problem-solving skills with strong ability to persuade and influence at the project team level and management level
- Good communication skills and ability to lead by influence
- Willingness and ability to travel (not expected to be more than 15% - 20%) on a national and international basis
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Clinical Research MD