Clinical Project Physician - Basel - 12 month contact

​RBW Consulting are proud to be partnered with one of the worlds leading Biotech's in their search for multiple Clinical Projcet Physicians to be based out of Basel for a 12 month contract starting ASAP!

The Clinical Project Physician is responsible for providing medical guidance, and oversight on clinical development projects under his/her responsibility from concept generation to design, leading medical discussions internally and externally.

The Clinical Project Physician:

• Contributes to the medical oversight of clinical trial(s) running in the project

• Answers to medical/scientific questions from ECs and Health Authorities for trials

• Ensures project(s)/trial (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

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

• Actively contributes 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 assures production of high-quality documents

• Provides medical leadership internally for all responsible project and trial(s) 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

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

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

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

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

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

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

• Contributes to clinical/scientific content for interaction (briefing book, submission dossier) with regulatory agencies and IRBs/ethics boards

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

Candidate Requirements

• MD preferably cardiologist/nephrologist with hands-on and results driven attitude

• At least 10 years post qualification experience in clinical research in Pharmaceutical or Biotech company

• Deep knowledge of drug development and clinical trial process based on previous deliverables

• Excellent knowledge of regulatory requirements and GCP/ICH guidelines

• Ideally has successfully led late-stage development and preferably submission process of a drug

• Comfortable playing as a team member and engaging all team members to take leadership roles in making suggestions and driving clinical programs through to completion

• Demonstrated experience in overseeing several clinical trials from a medical perspective including data review

• Experience in direct interactions with Health Authorities

• Clinical research experience in the cardiovascular and/or renal domain

• Good organizational, problem solving, interpersonal and communication skills

• 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

Please apply here and Harry Henson will be in contact to discuss your application further!