Senior Feasibility Manager

Role: Senior Feasibility Manager

Location: Hybrid - London, United Kingdom

Company: Global Clinical Research Organization

Planet Pharma are current working with a Global Clinical Research organization who are providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our clients are on a mission to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective!

In this role, you will be a member of our global clinical operations team. By working cross functionally with our clinical operations, medical and regulatory submissions teams, as well as through analyzing data from internal and public data sources, this individual will provide strategic insights on country selection and enrollment planning for global clinical trials

Job description:

• Lead feasibility assessments for high priority clients in support of proposal development for new business opportunities, and provide high quality, accurate feasibility data and analysis to internal and external teams;
• Present feasibility results to members of the proposal team to assure correct assumptions were applied and strategy is in line with our therapeutic and operational experience;
• Provide mentoring support, training and guidance to more junior members of the team, including entry level feasibility coordinators.
• Work collaboratively with project teams to support preparation for bid defense meetings; and
• Suggest improvements to the client feasibility process and implement systems to ensure the timely and accurate production of feasibility text and analysis.

Requirements / Qualification:

• Robust experience of small molecule dosage forms, particularly sterile and oral products. Familiarity with biological products will be an advantage.
• Robust experience with preparation of documentation for minor and major CMC post-approval variations.
• Experience of extension applications for new strengths and/or pharmaceutical dosage forms.
• Experience with EU submissions via the Centralized Procedure.
• Demonstrable knowledge of EMA and ICH regulatory CMC/Quality guidelines
• Experience supporting the preparation of CMC documentation for IMPDs, new product EU MAAs and PIPs will be an advantage.
• Direct agency interactions and preparation of scientific advice briefing documents for CMC related content and/or questions will be an advantage.

To Apply:

• Bachelors degree in life sciences required, Masters or PhD preferred;
• 3-5 years of feasibility experience within a CRO;
• Analytical thinker with great attention to detail;
• Proven ability to mentor more junior team members;
• Ability to analyse data and translate to meaningful recommendations;
• Ability to prioritize multiple projects and tasks within tight timelines; and
• Excellent written and verbal communication skills

To apply:

For more information on this position or any similar opportunities please contact Elias Adem at eadem@planet-pharma.co.uk and we can arrange a time for a confidential discussion about this role.

If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

Planet Pharma are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age