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 Project 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!