Biopharmaceuticals - Global Program Medical Director (m/f)

Biopharmaceuticals - Global Program Medical Director (m/f)
• Lead the International Clinical Team (ICT), and serve as clinical core team member of the International Project Team (IPT). Ensure alignment between program strategy and clinical development activities
• Lead author of the Clinical Development Plan. Lead the identification of the medical and clinical development implications of pre-clinical findings, drug formulation constraints, regulations and any other findings preceding the start of the first-in-human clinical study
• Accountable for the clinical development program from both strategic and day-to-day operational perspective
• Accountable for medical training of all relevant contributors to clinical development of assigned compounds
• Provide clinical leadership in interactions with external and internal stakeholders as well as internal decision boards Lead the development of program related presentations for such audiences in order to support the timely, quality planning, execution and submission of assigned programs
• Represent the company in the interactions with external stakeholders
• May serve as clinical lead and represent department in due diligence/in-licensing activities
• Lead and/or contribute to multidisciplinary tasks forces to support continuous improvement in BCD
• Achieve agreed targets in terms of quality, time and cost
• Clinical components of regulatory submissions are adequate to support approval
• Establish sound and trustful relationship within IPT and with all internal and external partners
• Adapt activities to the ever changing regulatory and operational requirements and environment
• Allow fast decision making by adequately gathering and presenting relevant facts
• Contribute to the development, innovation and improvement of BCD’s working standards and basic values
• MD, preferably with specialisation in Oncology, Rheumatology or Dermatology; additional training in areas such as statistics and pharmacokinetics desirable
• At least 10 years of clinical development experience in industry including:
- Experience in conducting phase 3 clinical trials from design to reporting
- Experience in regulatory submissions, reviews and approvals in at least a major region (e.g. EU, US or Japan)
- Knowledge of advanced clinical trial design, statistics and pharmacokinetics
- Proven ability to interpret, discuss and represent efficacy and safety data
• More than 5 years people management experience which may include management in a matrix environment; global people management experience desired
• Strong management, interpersonal, negotiation and problem-solving skills
• Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including experience working cross-functionally and in global teams
• Demonstrated technical knowledge and innovation in clinical development study designs that provide relevant evidence to decision-makers
• Proven learning agility: comfortable with complexity and able to explain complexity in simple words.
• Excellent English (oral and written)
BioPharma SZ
Oberhaching (near Munich)
Hexal AG
Research & Development
Full Time