Clinical Project Physician - Pulmonary Hypertension

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Project Physician – Pulmonary Hypertension to be located in Allschwil, Switzerland or Raritan, NJ . 
 
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information. 
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .
 
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
 

The Clinical Project Physician (CPP) is responsible for providing medical leadership, oversight and guidance on clinical development projects under his/her responsibility (or in which he/she is involved) from concept generation to design, implementation, execution, and submission/approval.

The incumbent is responsible for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures

The CPP may act as Study Responsible Physician (SRP) and lead the CFTT together with the Global Trial Leader (GTL). He may represent the medical lead for the specific assigned project in the Clinical Team (CT).

Responsibilities include:

1. Contribute to study design, medical input into protocol development (e.g. inclusion/exclusion criteria and other safety-related clinical considerations) and implementation of clinical studies.
2. Responsible for site interactions in partnership with the Study Responsible Scientist (SRS) for medical questions and education (including safety management guidelines).
3. Contribute to clinical/ scientific content for submissions to regulatory agencies and IRBs/ ethics boards, answer to medical/ scientific questions from Health Authorities and be the company clinical expert at meetings with them.
4. Performs medical data review, including evaluation of adverse events and eligibility of participants.
5. Responsible for assessment of key safety-related serious adverse events in partnership with the Local Safety Officer and the Medical Safety Officer and oversees safety narratives.
6. Reviews, evaluates and reports results of clinical studies in preparation for new drug application to the regulatory agencies.
7. May lead medical aspects of study-related committees (e.g. clinical advisory boards, steering committee, data monitoring committees…) interactions.
8. Contributes to the development and execution of clinical research programs for assigned company products (e.g. Clinical Development Plans, Clinical Overviews, HAs' Briefing Books, HAs' Annual Reports, Pediatric Investigational Plans, etc) with a strong strategic focus based on knowledge of the asset/drug, disease area, and relevant science to meet regulatory and disease strategy targets. Ensure production of high quality documents.
9. Ensures that all activities are in compliance with department, company and regulatory standards and procedures.
10. As requested, participates on cross functional teams for evaluation of new product ideas, implementation of business strategies, improvement of processes, etc.
11. Maintain personal knowledge of assigned therapeutic indication(s).