Senior Medical Affairs Manager, UK

4 weeks ago

Manchester, United Kingdom Chiesi Group Full time
Job Objective

This position is designed to assist the Associate Medical Director in executing the strategic medical agenda for designated therapeutic areas, while collaborating with the Medical leadership team to ensure operational excellence within the UK and Ireland (UKI) Medical Affairs division.

Candidate Profile

A robust scientific foundation in medical or biological sciences is crucial for this position, ideally with qualifications such as a GMC registered physician, GPhC registered pharmacist, or a PhD/Masters. Strong communication and interpersonal abilities, along with exceptional strategic planning and organizational skills, are vital for success in this role. Effective management of teams and projects necessitates the ability to prioritize tasks efficiently, balancing both immediate and long-term objectives, while demonstrating a history of successful cross-functional collaboration. A comprehensive understanding of Good Clinical Practice (GCP), Pharmacovigilance regulations, and the ABPI Code of Practice is essential, along with experience as a Final Signatory (Medical or AQP).

The key competencies required include well-honed communication skills paired with the capacity to strategically plan, critically evaluate progress, and implement changes in collaboration with both external and internal stakeholders.

This role will primarily be based in the Head Office, with opportunities for external engagement with Key Opinion Leaders (KOLs).

Key Responsibilities


• Oversee line management, ensuring regular one-on-one meetings and performance evaluations are conducted.

• Maintain comprehensive knowledge of relevant products and disease areas to serve as a medical expert.

• Participate in pertinent national and international scientific conferences to stay informed about therapy areas and gather competitive insights.

• Collaborate with the Medical leadership team to formulate the UKI Medical Affairs strategy supporting the medicines within the designated therapeutic areas, including planning for UKI phase IIIb and IV clinical trials.

• Ensure the execution of relevant UKI Medical Affairs strategies through established metrics.

• Organize and execute national advisory boards in alignment with the UKI Medical Affairs strategy, and provide support to MSLs and/or Medical Managers for regional advisory boards as needed.

• Manage UKI activities in Phase III & IV clinical development, including local investigator-initiated studies.

• Assist the Associate Medical Director in budget forecasting, ensuring alignment of overall budget with relevant strategies.

• Maintain regular communication with the external medical community to stay updated on field issues and provide medical support and guidance, while informing internal stakeholders of clinical advancements.

• Develop and sustain relationships with relevant UKI Patient Organizations in the therapeutic areas of interest.

• Actively participate in brand team and concept meetings as part of a cross-functional matrix team.

• Collaborate with local Regulatory Affairs and Market Access teams to devise optimal strategies and tactics for market access of new and established compounds in their therapeutic areas.

• Provide local medical expertise to UKI and global commercial teams.

• Work with the training department to support the education of medical and commercial teams on clinical and medical matters.

• Conduct Final Signatory reviews and approvals of materials and activities to ensure compliance with the ABPI Code of Practice.

• Collaborate with Market Access to facilitate access to therapeutic area medicines for HTA submissions.

• Proactively manage projects to completion independently, anticipating and resolving potential challenges collaboratively.

• Ensure adherence to all statutory requirements, internal processes, and procedures for Pharmacovigilance.

• Responsible for delivering Risk Management Plans in relevant therapeutic areas.

• Ensure all activities and interactions comply with applicable local, global, and national laws, regulations, guidelines, codes of conduct (including but not limited to the ABPI Code of Practice), company policies, and accepted best practices.

Role Requirements


• A medical/pharmacy degree or Masters/PhD is preferred.

• Proven relevant industry experience is essential.

• Line management experience is advantageous.

• In-depth knowledge of the ABPI Code of Practice, with final signatory status.

• Demonstrated organizational skills in managing multiple projects across various therapeutic areas simultaneously.

• Experience in a cross-functional team environment.

• Understanding of the UKI healthcare and market access landscape, with the ability to partner with healthcare providers.

• Familiarity with Good Clinical Practice (GCP), pharmacovigilance requirements, and regulatory/legal frameworks.

• Extensive knowledge and experience in Medical Information.

• Willingness to travel as part of the role to support the UKI Medical Affairs strategy and attend domestic and international conferences, including occasional weekend travel.

Key Competencies Include


• Resilience and the ability to perform in a challenging external environment.

• Capability to engage and manage multiple stakeholders (both internal and external) to achieve objectives.

• Curiosity and learning agility.

• Creative and strategic thinking abilities.

• Operational excellence with adaptability.

• Organized with a systematic approach to prioritization.

• Strong communication and presentation skills.

• Process-oriented to achieve business objectives with excellent cross-functional collaboration.

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