Location: Switzerland - Meyrin/Geneva
Division: Research and Development
Company: OM Pharma
Seniority Level: Senior Manager
In this newly created position, we are searching for a Drug Development Lead. As an expert in drug development, you will be responsible to bring the OM Pharma pipeline products to the market in an efficient and timely manner. In collaboration with the Drug Development Teams, you will be responsible to lead one major program. You will report to the Chief Scientific Officer and your tasks and responsibilities will include the following:
- In collaboration with the drug development team, you will create product development paths and deliver the vision and strategy for new or existing product based on multiple biological entities
- Represent the assigned development program to governance committees to enable timely and well-informed decision and milestones
- Engage senior leaders and functional area stakeholders to ensure alignment of development strategy and operational plans with functional area capabilities
- Lead the cross functional development team
- Build a high performing team culture by engaging matrix team members on the vision and ensuring clear team member roles and responsibilities, promoting team cohesiveness to optimise performance, and mediating conflict resolution
- Clearly communicate evolving program risks, implications of changes, and progress toward key milestones.
- Successfully drive operational execution of the approved program strategies
- Ensure that all GxP quality requirements along development plan are fulfilled
- Define project goals and objectives in alignment with corporate strategy, R&D strategy and defined TPP
- Holistically assess data needs for registration (including market access needs) and non-registration data generation across development phases
- Partner with both internal and external teams to develop and execute a Publication Strategy for primary and secondary publications of clinical data
- Secure required headcount and budget to achieve overall development plan and drive allocation and prioritisation of activities across Research and Development, and broader involved functions
- Maintain detailed records of all work to ensure compliance of all product submissions according to regulatory requirements
- Oversee relevant sub-teams and ensure clear goals and performance standards are in place, provide feedback and coaching, and hold sub-team leaders accountable for key deliverables
- Risk management: monitor risks, develop and implement mitigation plans to maintain and ensure delivery
- Plan and manage budget and resources of the development program
- Assist business development in preparation of business case proposals
- Contribute to identify IP opportunities
The ideal candidate has a PhD in a scientific field in addition to the following skills and experience:
- 10-15 years scientific expertise demonstrated in the pharmaceutical industry, specifically related to the drug development process, with an emphasis on biopharmaceuticals and/or pharmaceuticals development
- Minimum of 10 years’ experience in different functional areas from early to late stage development
- An up to date awareness of ICH and regional Regulatory Guidelines as well as experience on GCPs and/or updated product development training is essential
- Experience with regulatory health authority interactions
- Professional level French and English, both in oral and written communication
OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.