Medical Director Oncology (all genders)

Your role

As the Medical Director in Global Clinical Development, you will serve as the medical lead for clinical trials, providing oversight for the execution of clinical trial activities in assigned oncology/immune-oncology projects. Your role will involve managing clinical trial activities to best support the overall program strategy and leading the planning and management of clinical trials, including study design, trial management, data assessment, interpretation, and publication of results from a medical perspective. Additionally, you will engage and collaborate with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to develop the scientific rationale for clinical trials. You will also oversee the preparation of clinical development plans, study concept sheets, study protocols, and regulatory documentation in collaboration with clinical and project team members for assigned indications/products or with external partners for collaborative studies.

In this role, you will actively contribute to the medical writing of medical sections of study protocols, investigator brochures, and other regulatory documents. You will be responsible for managing the clinical team supporting the clinical trial and for mentoring and developing assigned staff. Co-leadership of trial teams and oversight of all aspects related to the scientific and medical risk in collaboration with safety representatives and other relevant stakeholders are also key responsibilities.

Your role will involve supporting the review, analysis, and interpretation of study data and communicating study results. It is essential to stay up-to-date in the assigned therapeutic area and sub-area, including oversight of significant new developments. Furthermore, you will contribute to the progress of the organization by providing input into assigned business process improvement workstreams and tasks.

Your main interfaces will be with the Global Development Unit Immuno-Oncology/Oncology, Global Development Team, Global Patient safety, Global Development Operations, Biostatistics, Global regulatory & quality assurance, Global Business Franchise, Medical Writing, and Global Medical Unit.

Who you are

Education & Languages:
- Possess a Medical Degree (mandatory)
- Board certification or training in Medical Oncology or Internal Medicine preferred but not mandatory
- Proficient in effective communication in English
- Demonstrated good medical writing skills

Professional Skills & Experience:
- Substantial professional experience in oncology, particularly in clinical trials, preferably early phase clinical trials
- At least 2-5 years of experience in the pharmaceutical or biotechnology industry, including knowledge of regulatory requirements in clinical development
- Proven experience in the design, setup, conduct, and evaluation of clinical trials in oncology
- Background in working in a cross-functional, multi-site team environment
- Experience in immuno-oncology and/or oncology research or translational aspects preferred

Personal Skills & Competencies:
- Ability to thrive in an intense, fast-paced, global work environment
- Possess a pro-active, problem-solving, and constructive attitude
- Strong oral and written communication skills, including delivering presentations (posters, papers, seminars) to internal and external parties
- Capable of seamless collaboration with project/program/functional teams, both face to face and remotely
- Proficient at processing complex medical-scientific topics and translating them into clinical development scenarios
- Ability to maintain familiarity with rapid progress in the field

Department: HC-RD-ODA Antibody Drug Conjugates

Job evaluation: AT - Expert 4