Proclinical is advertising a vacancy for an International Medical Director position with a growing speciality pharmaceutical company that develops and commercialises prescription medicines. This organisation, which focuses on drug development and state-of-the-art technologies in oncology, nephrology, and immunology, is seeking for an applicant to join their team in London on a contract basis.
The International Medical Director will help develop, coordinate, and complete International Medical Affairs activities related to rare diseases. They will implement International Medical Affairs Therapeutic Area strategies, including submission planning and subsequent ongoing lifecycle-driven revisions. Furthermore, they will assist in developing and implementing the company's communication strategy.
Job Responsibilities:
- Refining Actual Asset Profiles of portfolio compounds
- Providing input into labelling processes and negotiations to optimise the transparency of Benefit: Risk profiles and the relevance of labels to clinical practice.
- Supporting payer/market access strategies.
- Validating proposed promotional claims for the brand as supported by the label.
- Collaborating with the commercial team to inform the marketing strategy and sales story.
- Reviewing and approving core central marketing and promotional materials.
- Ensuring the consistency of approach between regions (US/EU/Asia) and representing the affiliates medical needs as required.
- Supporting the development organisation with publication planning of pivotal trials.
- Implementing the communication strategy in the Affiliates, including requested support to Clinical Operations.
- Evaluating the medical needs, as well as the clinical, operational, and reputational parameters for the introduction of any proposed pre-authorisation Early Access Programmes.
- Supporting and coordinating affiliate communications and activity planning to optimise the introduction of rare disease products.
- Collaborating with Affiliate Medics and International Marketing to develop and lead External Scientific Engagement activities, patient advocacy, activity planning, and scientific organisation strategy.
- Collaborating with Affiliate Medics to define and/or lead congress activity, disease-based education, and product-based education for internal and external stakeholders.
- Developing and delivering the publication plan partnering, as required, to support evidence generation and dissemination.
- Overseeing the development of responses to medical information requests and being accountable for the accuracy of standard responses.
- Leading and delivering ongoing international lifecycle data generation, including overseeing unsolicited investigator sponsored trial proposals and real-world evidence gathering.
- Representing the affiliate companies and providing the medical lead into head office regulatory, QA, and pharmacovigilance discussions and documentation in the development and maintenance of all rare disease marketing products. This includes reviewing and signing off on commercial and regulatory documents, such as labelling or benefit-risk statements.
- Attending meetings with regulatory authorities or other agencies, as necessary.
Skills and Requirements:
- A relevant scientific degree or appropriate certification, with a preference for medical qualifications.
- At least ten years of industry experience, with previous experience in bone, rare disease, and/or biologics.
- Demonstrable Medical Affairs experience in the EU, with experience in the US highly desirable.
- A strong background in Medical Affairs, especially during launch phase; experience in development also desirable.
- Proven success in working on an international level.
- A broad understanding of healthcare delivery environments and the role of the EU and US pharmaceutical industries within them.
- A comprehensive understanding of industry medical and financial governance norms, particularly with reference to compliance with all laws, regulations, and codes of scientific and promotional practice.
- A proven track record of delivering value added medical offerings.
- Capable of influencing stakeholders.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Director Level.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Green at +44 203 814 1317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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