Medical Affairs Lead, UK

2 months ago

Manchester, United Kingdom Chiesi Group Full time
Job Purpose

The role will support the Associate Medical Director in delivering the strategic medical plan for the allocated therapy area(s) and work in collaboration with Medical leadership team to deliver operational excellence of the UK and Ireland (UKI) Medical Affairs team.

Profile

A strong scientific background in medical or biological science is essential for this role, preferably a GMC registered doctor, GPhC registered pharmacist or a PhD/Masters. Confidence in communication and interpersonal skills with excellent strategic planning and organisational skills, are essential to success in this role.  In managing a team and projects, there is a requirement to prioritise work effectively; balancing both long and short-term requirements and be able to demonstrate previous excellent cross functional working. It is key to have a good working knowledge of Good Clinical Practice (GCP), Pharmacovigilance laws and regulations and the ABPI Code of Practice, and be an experienced Final Signatory (Medical or AQP)

 

The defining skills therefore, will be well-developed communications skills combined with the ability to strategically plan, critically appraise progress, and work towards implementing change with external and internal stakeholders.

 

The role will be predominantly Head-Office based, with some degree of external KOL engagement

Responsibilities

•    Line management, ensuring regular 1:1s and performance reviews are undertaken
•    Maintain in-depth knowledge of relevant products and relevant disease area in order to act as an expert medical resource
•    Attend relevant national and international scientific meetings/congresses to ensure up-to-date knowledge of therapy area(s), and gather competitive intelligence
•    In collaboration with the Medical leadership team, develop the UKI Medical Affairs plan to support the medicines within the therapy area(s), including UKI phase IIIb and IV clinical trial planning.
•    Responsible for the execution of relevant UKI Medical Affairs Plans through agreed metrics
•    Develop and execute national advisory boards in line with the UKI Medical Affairs Plan. Provide support to MSL(s) and/or Medical Managers to plan and execute regional advisory boards on ad hoc basis
•    Management of UKI activities in Phase III & IV clinical development, including local investigator-initiated studies
•    Support the Associate Medical Director in forecasting budget, and be responsible for ensuring overall budget remain in close alignment with forecast for relevant strategies
•    Regular communication with the external medical community to remain abreast of issues in the field and to provide medical support and direction to them and inform internal stakeholders of clinical developments
•    Develop and maintain working relationships with relevant UKI Patient Organisations in therapy area(s) of interest
•    Attend and proactively participate in brand team and concept meetings as part of a cross functional matrix team
•    Collaborate in a cross-functional team effort with local Regulatory Affairs and Market Access to develop best strategy and tactics to support market access for new and established compounds in their therapy area(s).
•    Provide local medical expert input into UKI and global commercial teams
•    Work with the training function to provide support to train and educate the medical and commercial teams on clinical and medical issues
•    Final Signatory review and approval of materials and/or activities for compliance with the ABPI Code of Practice
•    Work in a collaborative manner with Market Access to support access to therapy area medicines for HTA submissions to NICE, AWMSG and SMC.
•    Proactively manage projects to completion in independent manner, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner
•    Ensure compliance with all statutory requirements, internal processes and procedures for Pharmacovigilance
•    Responsible for the delivery of Risk Management Plan(s) in relevant Therapy Area
•    Ensure that all activities and interactions are conducted in compliance 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 standards of best practice Role

Role Requirements

•    A medical/pharmacy degree or Masters/PhD is preferable 
•    Demonstrable relevant Industry experience is essential
•    Line management experience preferred
•    In-depth knowledge of ABPI Code of Practice, with final signatory status
•    Demonstrable organisational skills in managing multiple projects in multiple therapy areas simultaneously
•    Experienced in working in a cross functional team environment
•    Understanding of UKI healthcare and market access environment and ability to partner with healthcare providers
•    Experienced in implementing Good Clinical Practice (GCP), pharmacovigilance requirements and regulatory /legal framework
•    In-depth knowledge and experience in Medical Information
•    Ability to travel as part of role to support the UKI Medical Affairs plan and to attend domestic and international conferences. Occasional weekend travel will be required

Key Competencies Include

•    Resilience with the ability to deliver in a challenging external environment
•    Ability to engage and manage multiple stakeholders (both internal and external) to achieve the objective(s)
•    Curious with learning agility
•    Creative and strategic thinker
•    Operational excellence with good adaptability
•    Organised with systematic approach to prioritisation
•    Strong communication and presentation skills
•    Process orientated to achieve the business objective with excellent cross functional working

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