Senior Medical Director, Early Clinical; Development (Oncology/Immuno-Oncology) - Zurich, CH
Company: Advanced Clinical Recruitment Ltd
Location: Zurich, Switzerland
Closing Date: 28 Feb 17
Salary (£): Competitive
My client a highly innovative biotech based in Zurich, Switzerland is currently looking for a Senior Medical Director, Early Clinical Development (Oncology / Immuno-Oncology).
In this role you will be responsible for being the Medical Expert providing clinical expertise and business direction to development programs.
- Provide medical research expertise, for internal (clinical operations, regulatory affairs, pharmacovigilance and safety monitoring boards) and external (health authorities, ethics committees, research oversight and funding committees, key opinion leaders, investigators and patients) stakeholder requirements.
- Interact with various stakeholders (strategic partners, external (therapeutic) experts, academic institutions and societies)
- Provide the medical lead and input for clinical protocols and protocol related documents (e.g. ICF, statistical plans, study reports), IBs and IND/IMPD documents
- Participate in key regulatory meetings globally, prepare documents and submissions, including authoring clinical components of study reports, dossiers and presentations
- Contribute to the development of presentation materials for advisory boards, investigator meetings, scientific congresses, company presentations etc.
- Medical monitoring of assigned sponsored clinical trials and point of contract for study sites for any protocol related questions
- Interpretation of safety data in collaboration with pharmacovigilance and internal and external safety monitoring boards
- Review of clinical trial data providing expert analysis and interpretation
- Support and lead activities including the establishment and maintenance of contacts with investigators, key opinion leaders, patients and patient organizations
- Medical/scientific due diligence for in-licensing candidates and out-licensing of ongoing programs.
- MD degree
- Seasoned professional with a background in practicing medicine, clinical research, and familiarity with biostatistics, epidemiology and health outcomes preferred.
- Experience of successful drug development, with clinical research experience in a pharmaceutical or contract research organization.
- Sound understanding of medical information and medical marketing
- Medical writing
- Ability to interpret, discuss and present clinical data to critical audiences
- Excellent verbal and written communication skills in English
- IT knowledge
- Office software
- Soft skills
- Strong business acumen
- Excellent written and oral communication, interpersonal, and organization skills
- High level of emotional intelligence
- Ability to translate and appropriately align commercial and scientific goals and objectives
- Proven ability to interact productively with both commercial and scientific colleagues
- Demonstrated ability to work collaboratively in cross functional teams
- Highest level of ethics and integrity