Executive Medical Director Oncology Clinical Development

Key responsibilities

• Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biological sciences and data sources; as well as competitive environment
• Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned program(s) to ensure: successful delivery of the development plan, anticipation and dealing with uncertainties; generation of scenarios and relevant information for decision making; and managing risks
• Clinical deliverables may include but are not limited to clinical study synopsis and protocol(s), Investigator Brochure, program specific standards, clinical components of regulatory documents/registration dossiers, publications, and in-/out licensing activities
• Deliver and execute the clinical development plan(s) in collaboration with study teams by ensuring: efficient execution of protocols, appropriate study medical monitoring, timely resolution of issues and reporting of study results including communication at congresses
• Be an integral member of the clinical development team and drive execution of the clinical program(s) in partnership with other functions (e.g. Clinical Scientist(s), Project Management, Clinical Operations, Biostats, Regulatory Affairs and Business functions) to support decision milestones, regulatory requirements, market access and potential out licensing
• Responsible for the generation of the Clinical Development Plan (CDP) and is a major contributor to the Target Product Profile (TPP) and Integrated Project Plan (IPP)
• Present CDP and other study project-related topics to Leadership Team for validation
• Consult with internal and external experts for the generation of an innovative and optimal Clinical Development Plan including design and timing of individual study protocols
• Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., study teams, Translational Medicine, Regulatory Affairs), and internal decision boards
• Provide Clinical Development input in due diligences both for the in-licensing and out[1]licensing of compounds

Your profile:

• Medical Doctor with adequate clinical experience in oncology; Expertise in solid tumours is a must. Expertise in hemato-oncology or radio-oncology is a strong plus
• 7-10 years of successful and solid experience in oncology early and late drug development (from First In Human to Phase III study) in the pharmaceutical industry, including in best practice big pharma
• Evidence of keeping up to date with the recent development in clinical practice and scientific progress
• Track record of having led at least one oncology development program through different stages
• Proven track record delivery and publication of clinical trials in oncology an/or hematology. Open-mindedness, flexible, with a high level of scientific / medical curiosity and strategy mindset
• Being able to deal with uncertainty, manage risks and drive a proper decision making
• Proven strategic thinking and innovative mind-set, combined with project management and operational skills
• Leadership and ability to collaborate in a team within a matrix organization, while remaining autonomous and entrepreneurial minded
• Proven ability to establish strong scientific partnership with key stakeholders
• Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process and of ensuring compliance with GCP, SOPs, and regulatory requirements