Clinical Project Physician - Cardiology

Employer
Location
Switzerland, Switzerland
Salary
Competitive
Posted
Dec 06, 2017
Closes
Dec 14, 2017
Ref
959700891
Contract Type
Full Time
Job Type
Medical Doctor
POSITION OVERVIEW

The position will provide medical leadership, oversight and guidance on clinical development projects from concept generation to design, implementation, execution, and submission/approval. The CPP represents the Clinical Science medical lead for the assigned project(s) in the life cycle teams. The ultimate goals and accountabilities of this position include:

- Provide medical leadership internally for clinical science project activities through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to cardiology clinical trials;
- Provide medical leadership externally based on thorough scientific review of relevant product data and consultation with internal and external experts;

- Maintain personal knowledge base of assigned therapeutic indication(s)

ACCOUNTABILITIES

- Accountable for delivering the medical aspects of the Clinical Project Development Plan (CDP), and overseeing its implementation;
- Contribute medical and scientific input, as a core member, to the strategic decisions of the life cycle team for assigned project(s);
- Undertake product and therapeutic area reviews to contribute to global strategic development and provide evidence-based input to the study-related, strategic and regulatory documents;
- Contribute to the core medical/scientific information required in all clinical documents (e.g. protocols, core informed consent forms, clinical study reports, investigator's brochure, clinical components of regulatory submissions, safety related documents, and others), and assure production of high quality documents;
- Organize and lead medical aspects of clinical advisory boards, steering committee meetings and data monitoring committees;
- 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;
- Represent the company at key regulatory interfaces, investigator meetings, internal team and management meetings as well as partner meetings;
- Provide medical input on behalf of clinical science to the monitoring and analysis of the safety profile of the product, together with Global Drug Safety;
- 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.
- Lead the development and maintenance of contacts with Key Opinion Leaders and Investigators;
- Plan and execute publication and clinical communication strategy in coordination with Medical Communications;
- Upon request of management, support the assessment of new in-licensing opportunities.

Requirements

- Board certified Medical Doctor in Cardiology, or other specialization if post-degree experience in cardiology clinical development.
- An MD/PhD dual degree would be an advantage.
- Proven clinical and scientific expertise in the areas of cardiology;
- Expert knowledge and proven track record in the field;
- Experience in Clinical Research, with a scientific and medical understanding of phase I to III clinical trials, gained in the Pharmaceutical or Biotech industry, with a CRO, or in an Academic institution, ideally in cardiology;
- Sound knowledge of drug development and clinical trial process;
- Sound knowledge in International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations and standards.
- Fluency and excellent communication skills in English, any other languages are a plus.