Johnson & Johnson Careers

Clinical Leader

Allschwil, Switzerland
Clinical Research MD


Job Description

Requisition ID: 1905758642W

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
 
Actelion is a leader in the field of pulmonary hypertension (PH). Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
 
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
 
Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for an:

Clinical Leader
in Switzerland/Allschwil.


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.
 
Provide medical leadership internally:
  • 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.


Qualifications
  • 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 
     
Competencies
  • 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


Primary Location
Switzerland-Allschwil--
Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
Clinical Research MD
Requisition ID
1905758642W