Clinical Physician - Oncology

Job content

NonStop are currently looking to speak with Clinical Research Physicians who are interested to work near the Basel area. We are currently working with a mid sized Pharma, looking for someone to join their team on-site for at least a contract until the end of the year, which is likely to be extended.

The company has sound financial backing as well as state of the art facilities which will enable you to gain vast amounts of experience with a credible name, which will accelerate your career development.

All tasks below are required to be performed in compliance with Good Clinical Practices and SOP’s. Overall, the CPP 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 TA-responsible project activities (e.g. to LCT, Clinical Team, Regulatory & Safety aspects), through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area

• Provide medical and scientific input, as appropriate, to the strategic decisions of the Life Cycle Team for the assigned project(s)
• Contribute to global strategic development and provide evidence-based input to the clinical project related, strategic and regulatory documents
• Deliver the medical components of the Clinical Development Plan (CDP) related to the project indication(s) and oversee its implementation
• Contribute as needed to trial level medical activities
• As a member of the DSRC for assigned project(s), provide medical input on behalf of TA to the monitoring and analysis of the safety profile of the product, together with Global Drug Safety
• 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
• Upon request of management, support the assessment of new in-licensing opportunities

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
• Lead medical aspects of clinical advisory boards and study specific committees (e.g., steering committees (SC), Independent Data Monitoring Committees (IDMC), 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, patient organization meetings as well as partner meetings where applicable
• Provide input to and execute publication and clinical communication strategy
  

Candidate Requirements

• MD
• Extensive experience in clinical research in a clinical research organization (CRO) or Pharmaceutical Company
• Demonstrated experience in overseeing clinical projects from a medical perspective
• Clinical research experience in the indication relevant to the Clinical Project is preferred
• Sound knowledge of drug development based on previous deliverables
• Sound knowledge of regulatory requirements/ICH guidelines
• Good organizational skills, able to work as part of a cross-functional team and independently
• Ability to work collaboratively in a matrix environment
• Strategic thinking
• Hands-on approach
• Excellent written and spoken communication skills
• Fluent in English (written and oral)
  

Behavioral skills

• Good organizational, problem solving, and interpersonal and communication skills
• Ability to work independently and within a cross-functional team to prioritize and coordinate multiple competing tasks
• Ability to work under pressure and meet short timelines without compromising quality
• Results driven attitude and good sense of urgency
• Able to anticipate and proactively address issues and demands
• Analytical thinking, data and detail oriented
• Shares knowledge and expertise openly
• Effectively negotiates with key stakeholders to influence, convince, and gain their buy-in and agreement
• Thinks globally and has an understanding of the big picture (e.g., competitor activities, potential
• implications and consequences of own activities and decisions)
• Good leadership skills, ability to represent project internally and externally
  

Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstopconsulting.com or +41 435 080 817, please send your CV in word format ORif this does not sound like the opportunity for you, but you are a Contract professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.