Job Detail

Clinical Project Physician

Inseriert am: 20.09.2018

Clinical Project Physician

Location: 

Basel Area - Allschwil, BL, CH


 


 


About Idorsia Pharmaceuticals Ltd


Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.


In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.


Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.


Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.


Job Responsibilities


 


Overall the Clinical Project Physician is responsible for providing medical leadership, oversight and guidance on clinical development projects under his/her responsibility from concept generation to design, implementation, execution, and submission/approval.


 


The Clinical Project Physician represent the medical lead for the specific assigned project in the life cycle teams.


 



  • Provide medical leadership internally for all responsible project activities assigned (e.g. to LCT, Regulatory & Safety aspects), through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area

  • Responsible for delivering the medical aspects of the Clinical Project Development Plan related to the indication and overseeing its implementation

  • Actively contribute to the core medical/scientific information required in all clinical documents (e.g. Protocols, Core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high quality documents

  • Contribute medical and scientific input, where appropriate, to the strategic decisions of the Life Cycle Team for assigned project(s)

  • Contribute to global strategic development and provide evidence-based input to the clinical project-related, strategic and regulatory documents

  • Contribute as needed to trial level medical activities

  • Ensure project(s) is/are adequately supported medically and prioritized to ensure timely and on target delivery on set objectives and deliverables in line with clinical development goals

  • Provide medical input to the project-related communication/publication plan

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

  • Lead the development and maintenance of medical interactions with key external experts and investigators

  • Organize and lead medical aspects of clinical advisory boards and study specific committees (steering committees, data monitoring committees, safety event committees).

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

  • Be the company clinical expert at key regulatory interfaces, investigator meetings as well as partner meetings where applicable.


 


 


Candidate’s Requirements


 



  • MD

  • At least 5 years’ experience in clinical research gained in a Pharmaceutical Company or Clinical Research Organization (CRO)

  • Demonstrated experience in overseeing clinical projects from a medical perspective

  • Clinical research experience in the indication of one of Idorsia’s Therapeutic Areas is of preference

  • Sound knowledge of drug development based on previous deliverables

  • Sound knowledge of regulatory requirements/ICH guidelines

  • Good organizational, problem solving, interpersonal and communication skills

  • Hands-on and results driven attitude with a good sense of urgency

  • Effectively negotiates with key stakeholders to influence, convince, and gain their buy-in and agreement

  • Thinks globally and understands the big picture (e.g., competitor activities, potential implications and consequences of own activities and decisions)

  • Excellent written and spoken communication skills in English


 


What Idorsia offers



  • Exciting opportunities for development and professional growth within our dynamic organization

  • A collaborative and solution-oriented environment where you can make a difference

  • An innovative and open culture in a truly multicultural environment

  • A competitive salary and generous social benefits


 


Work Location: Allschwil
Country: Switzerland
Business Area: Global Clinical Development
Schedule: Fulltime
Job Type: Permanent
Job ID: 910


 


If you are interested, please click on apply now.


Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.


Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

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