This is an outstanding opportunity for an experienced regulatory professional in drug development and regulatory strategy in the biotech arena, specifically for Immuno-Oncology and cancer vaccines-based portfolio, to join motivated and newly formed Regulatory Science & Pharmacovigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.
The RSP aims to maximize opportunities for product approval, its safe use and further development by:
- Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
- Ensuring Operational excellence
- Delivering regulatory milestones and timely registration throughout the product lifecycle
- Building robust Phase IV systems and preparing for post-marketing commitments.
- Adhering to and fostering a culture of quality and compliance
- Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration
Agenus is seeking an experienced regulatory leader with over 13 years of experience in the international pharmaceutical industry or consultancy and at least 10 years in global regulatory strategy with proven track record of business impact. Management experience of cross-functional team over 5 years is a prerequisite. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and defending the regulatory position with global health authorities.
The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.
Who are we looking for?
- Innovative and enthusiastic Regulatory professional to join our team
- A candidate who loves to create dynamic development strategies and impactful registration approaches and is excited to translate cancer therapies into drugs that will make a difference to patients lives.
What are we looking for?
- Leading the way: A creative and learning-agile thinker, willing to challenge the status quo
- Ownership: A partner to jointly own our company’s goals, execution and success
- Working together: A colleague to thrive on collaboration with our global teammates
- Loving what you do: A team member with positive energy that is passionate about our mission
- Provide strategic regulatory leadership to project teams to support the planning and conduct of clinical & CMC development and operational excellence leading to successful and fast registration
- Identify issues from research, early development and evolving competitive intelligence that potentially would impact regulatory approval (risk analysis)
- Manage development projects with multiple, complex issues requiring extensive agency consultations and contingency and risk mitigation planning
- Assesses project plans and timelines effectively to ensure projects are appropriately prioritized and key goals are met on time
- Evaluate current regulatory processes and communication links and assess opportunities for improvement
- Leverage the changing regulatory landscape of science based, innovative and seamless clinical trial designs with use of surrogate endpoint.
- Utilization of expedited approval pathways for product development and registration with Health Agencies globally
- Innovative thinker with agility to create regulatory pathway for accelerated approval
- Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals
- Ensure completion of regulatory deliverables, according to agreed project timelines and development plans
- Work with cross-functional team in different business units (clinical, CMC, commercial, etc.) to formulate global regulatory plans and tactics
- Lead compilation of regulatory dossier and ensure readiness for submission to health authorities
- Manage global regulatory sub-team for specific projects composed of regulatory CMC, regulatory operations, regulatory intelligence and regulatory managers responsible for major markets
What are we offering?
- A dynamic and fun culture in a global setting: US, UK, Belgium
- Exposure to pioneering science and the full scope of the drug development process
- Innovative thinking: speed of adopting new technologies, clear prioritization, using analytics to accelerate agile development
- A unique opportunity to help develop the vision and strategy of a burgeoning company and the evolution of a new discovery team
- Leadership with broad experience, passionate about the science, who is a proven mentor with extensive Regulatory and Clinical experience
- Career support and leadership opportunities within a highly glad organization
The successful candidate should possess the following qualifications, experience and attributes…
- University qualification in a relevant life science discipline; preferably with a higher academic qualification (MD, PhD, PharmD)
- Substantial experience gained in regulatory affairs and strategy 13+ years, via roles in the pharma/biotech industry, consultancy or regulatory health agencies
- Experience in developing cancer vaccines will be desirable
- At least 10 years in regulatory development strategies, managing complex projects and FDA, EMA and other major agency consultations
- Track record of regulatory approvals in oncology is a must, including hands-on experience across all phases of development and post-marketing
- In-depth understanding of the current European and US regulations and the wider regulatory environment and trends – and their implications for the global drug development process
- Knowledge of ICH, FDA and EMA guidelines and awareness of evolving regulatory environment
- Established network and credibility with key customers including health authorities and industry
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Ability to influence and lead cross-functional team toward successful negotiation with agency
- Ability to influence and interact effectively with internal and external customers
- Ability to work effectively across functions in drug development and commercial organizations
- Team player with good interpersonal skills
- Strong oral and written communication skills
- Good presentation, organization and planning skills
- Able to undertake significant travel (approx. 30% a year)
- Fluency in English, written and spoken - knowledge of other languages valuable