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!
30+ days ago