Clinical Leader

Job Description Actelion pharmaceuticals ltd., a Janssen pharmaceutical company of Johnson & Johnson, is recruiting for a Clinical Leader Based in Allschwil.

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 is a leader in the field of pulmonary arterial hypertension (pah).

Our portfolio of pah treatments covers the spectrum of disease, from who functional class (fc) ii through to fc iv, with oral, inhaled and intravenous medications.

RESPONSIBILITIES AND TASKS OVERALL: 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 Program Input Provide support (with medical and scientific input) to strategic decisions of the Compound Development Team (CDT) for assigned project(s).

Accountable for delivering/maintaining a Clinical Development Plan (CDP), that addresses regulatory and clinical requirements for a successful program development strategy by discussing and addressing key scientific and medical issues Overall accountable for the scientific, ethic and regulatory conduct of all study related deliverables within his/her assigned program.

Accountable for content of medical input on behalf of Clinical Science to the monitoring and analysis of the safety profile of the product, together with the Project Physician / Study Responsible Physician and DRUG SAFETY PHYSICIAN.

This task may be delegated to the Scientific Leader as appropriate.

Interface with Research, Medical Affairs and Global Commercial Strategy.

Accountable for all clinical trial deliverables of assigned programs, along with the ongoing assessment / identification of program risk and implementation of mitigation strategies: Write and oversee development of scientifically sound clinical study documents (protocol, SAP, CSR) that are aligned with clinical development strategy Contribute clinical/medical expertise and content of clinical sections of regulatory documents such as briefing books, NDAs/MAAs etc Participate in tracking/analysis of any potential safety signal across clinical trials under his/her responsibility Supervises and supports Project/Trial-Responsible Physicians, as needed Interact with clinical investigators and Key Opinion Leaders as appropriate.

Work closely with Data Management and with Biostatistics and Data management.

Leads the review, interpretation and communication of study results.

Leads the development and compilation of clinical sections of NDA/MAAs and to support responses to Health Agency questions and HA presentations post-filing.

May review/co-author medical publications, emerging from clinical trial results.

Assess and plan for external clinical research opportunities in collaboration with the Clinical Leader and Business Development.

Provide External Medical Leadership (Delegate To Molecule Responsible Physician As Appropriate) Accountable for the development and maintenance of contacts with Key Opinion Leaders and Investigators.

Accountable for all clinical Advisory Boards, Steering Committee Meetings and Data Monitoring Committees.

Represent company at key regulatory interfaces, Investigator Meetings, internal team and management meetings as well as partner meetings where applicable.

Plan and execute publication and clinical communication strategy in coordination with Medical Communications.

Upon request of management, support the assessment of in-licensing opportunities and due diligence activities and presentation of recommendations to senior management.

Maintain Knowledge Of Therapeutic Area And Pharmaceutical Development Regulations Attend relevant medical conferences and therapeutic area postgraduate training as required, maintain knowledge of relevant literature and publications.

Ensure clinical trial activities comply with the highest quality/ethical standards Qualifications REQUIRED QUALIFICATIONS AND EXPERIENCE MD with clinical development experience > 8 years.

Post graduate training and clinical experience in the cardio-pulmonary area Record of successful management of project teams in a matrix environment Proven ability to lead a team of scientist and/or physicians 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 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 (