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PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and MedTech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.
Management or leadership of biopharma consulting projects and continuous development of our international Biopharma Excellence services and team as well as leading, developing and coordinating an international team, of international projects and initiatives as assigned. The successful candidate must have a minimum of 12 years of experience working for, or as a service provider to pharmaceutical or biotech companies with diverse experience in biologics and advanced therapies. Candidates must have demonstrated expertise in developing clinical and regulatory strategy and leading or playing a key role in Regulatory Agency meetings and submissions.
PharmaLex is a proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
Senior Director Principal Consultant Biologics and Advanced Therapies
- Scientific or project lead on multiple, possibly simultaneous biopharmaceutical development projects
- Strategic input into and management of global regulatory Agency meetings and submissions
- Research and recommend global development and regulatory/clinical strategy, as well as navigating clients through the development process
- Client interactions for scoping calls, workshops, presentation of complex strategic workshops, etc.
- Mentoring of other consultants and biopharma trainees
- Review and approval internal docs for release to clients
- If applicable, economic steering and observation of all global projects within dedicated service
- Identification, training and coaching of dedicated employees globally in biopharma excellence in cooperation with the respective line managers
- Communication with clients and participation in / organization of bid defense meetings
- Responsibility / Accountability for the preparation of RFP/RFI and quotes in cooperation with the corporate and/or local sales and proposal teams
- Must have previous experience with biologics and/or advanced therapies including clinical and non-CMC regulatory strategy
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Very good command of written and spoken English
- At least > 12 years of experience in biopharma drug development and approval
- Has long-standing exposure to many different areas and different product classes with a broad and solid experience on how biopharmaceuticals are developed and regulated
- Lead project teams from client kick-off to final deliverable, contributing to and overseeing technical and regulatory activities
- Subject matter expert in more than one area relevant for biopharmaceuticals
- Ability to develop customized solutions to assist clients in moving asset through development
- Can solve very difficult technical questions
- Examples: development strategy, review/gap analysis of programs, dossier preparation and review, risk assessment, scenario planning
- Maintain 65% utilization on client projects
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.