Medical Head, Infectious Diseases
The Medical Head, Infectious diseases is a central medical / scientific function and acts as the leader for the clinical development projects. He/she reports into the Chief Medical and Development Officer and ensures information and alignment on all key aspects. The Director will work closely with the Project Team to develop and execute an aligned clinical development plan.
- Assume medical / scientific leadership for the pipeline clinical trials development, including development strategy, planning, execution, supervision of clinical studies, establishing and maintaining relationships with KOLs
- Provide strategic direction to the development activities for the assigned clinical project in close collaboration with internal stakeholders (Clinical Operations, Research and Pre Clinical Development)
- Create and implement the long term strategy for pipeline antibiotics life cycle management
- Work with early development team to establish full development strategy for pipeline antibiotics
- Provide medical expertise based on thorough scientific review in consultation with internal and external experts
- Provide clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with guidance. Clinical deliverables may include individual protocols, clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications. Ensure timely execution of assigned deliverables
- Provide scientific input into trial/program level documents such as protocols and related documents, IBs, briefing books for health authority meetings, PIPs, clinical overviews and summaries, depending on status of development
- Write and/organize writing and/or review of study related documents (protocol outline, protocol and protocol amendment, Informed Consent, Statistical Analysis Plan, Clinical Study Report, manuscript for publication). Answers medical/scientific inquiries from IEC/IRB and/or Health Authorities
- Drive execution of the section of the clinical program in partnership with stakeholders (e.g., Clinical Operations, CRO)
- Develop and maintain contact with clinical experts , organize and contribute to expert meetings and spend time at sites as needed to obtain clinical insights to guide program development and execution
- Supervise and contribute to development of assigned clinical team subordinates
- Participate at meetings with Health Authorities
- Manage or contribute to manage trial committees, advisory boards
- Develop a sound understanding of the science and medicine related to trials and pro-grams
- Provide scientific input and guidance for the development and execution of the publication plans
- Provide scientific input to the development and implementation of the post approval clinical trial plan
- Provide scientific support and medical / scientific task related guidance to CROs
- Conduct business in compliance with all applicable laws and internal directives and ac-cording to generally accepted standards.
Qualifications and Experience:
- University degree as Medical Doctor or University degree in a life science (i.e., PhD, PharmD, DVM) if together with substantial industry experience in a medical function.
- Infectious disease or Intensive care unit development experience strongly preferred.
- Minimum of 7 years of involvement in clinical research or drug development in a pharmaceutical company spanning all clinical activities on international level (planning, setting up, conducting, closing, and reporting) of Phase 1 through 4 clinical trials. Phase 3 is a strong preference.
- Advanced knowledge in Antibiotics/ Infectious diseases required.
- Strong leadership skills, ability to motivate and involve the staff
- Ability to foster scientific exchange, and engage in profiling and outreach to external experts in relevant therapeutic areas
- Good understanding of medical communications
- Regulatory submission experience – both IND and NDA preferred
- At least five years of demonstrated leadership and accomplishment in all aspects of clinical development activities in a global matrix environment.
- Strong management, interpersonal, communication, negotiation, and problem-solving skills.
- Excellent organizational ability and flexibility with attention to details
- Good time management skills
- Innovative, critical and entrepreneurial thinking with ability to organize and prioritize and to motivate teams
- Ability to effectively work in and contribute to multi-functional teams as well as in international environments
- Excellent and up-to-date knowledge of the ICH and Good Clinical Practice standards
- Fluent in English, oral and written (additional language skills are an advantage)