Job Detail

"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 Project Physician 

Your responsibilities:

• 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.


• Provide medical support externally based on thorough scientific review of relevant product data and consultation with internal and external experts.


• Be the key physician contact for sites and investigators during study start-up and study execution, act as a liaison between the company and clinical investigators, CRO’s, and CRA’s.


• Present trial- and compound- related information at Investigator Meetings and internal training sessions. 


• Participate in medical review, interpretation, and reporting of the results of the research, including submission to health authorities.


• Prepare medical narratives on research subjects as needed.


• 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.


• Support the development and maintenance of contacts with Key Opinion Leaders and Investigators.


• Support the organization of and active participation in the medical aspects of clinical advisory boards, investigator meetings, steering committee meetings, adjudication committee meetings, partners meetings, and data monitoring committees.


• Contribute to clinical/scientific content for submissions to regulatory agencies and IRBs / ethics boards, and answer to medical/scientific questions from Health Authorities.


• Execute publication and clinical communication strategy in coordination with Medical Communications.

Qualifications

• MD with at least 5 years of clinical / research experience


• Sound knowledge of drug development and clinical trial process


• Strong knowledge of regulatory requirements / International Council of Harmonisation (ICH) guidelines


• 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


• If based in the Cherry Hill (New Jersey) office, then international travel to the headquarters required, for at least 20% of the time


• Other intermittent domestic and international travel as well (not expected to be more than 10%-15% of the time on average)

Primary Location

Switzerland-Allschwil--


Organization

Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)


Job Function

Clinical Research MD


Requisition ID

1905735158W