In this role, the Medical Director will lead the strategy of the products under his/her responsibility. He/she will be responsible for designing and executing plans across the global businesses. As such, individual will have extensive cross-functional interaction within the Company, ranging from pre-clinical through to clinical, regulatory and commercial functions.
- To provide clinical leadership in cross-functional projects and product/project teams;
- Responsibility for developing and maintaining the overall medical strategy of the assigned product(s), for validating this strategy with appropriate internal or external experts and for agreeing the strategy with the appropriate internal business stakeholders;
- To be responsible that project activities and milestones are planned, agreed and achieved according to the overall plan (it includes pre and post marketing activities);
- To be responsible for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports;
- Verifies scientific accuracy of safety and efficacy summaries for regulatory/ commercial purposes and assists with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre or post-marketing activities;
- Working with the Quality Assurance, Regulatory Affairs and Pharmacovigilance teams to establish and maintain strong risk assessment and management processes for decision-making;
- Input into Risk Management reviews as it relates to patient safety, the performance of risk assessment in the design of new products, and the interpretation of patient safety and risk in the post-market environment;
- Collaborating with multiple functions to ensure patient safety, minimize risk, select products for development;
- Work with teams and outside experts to design plan and to support clinical research strategies for regulatory approval, reimbursement and adoption.
Qualifications/Requirements:
- Experience in Pharmaceutical, Biotech, Contract Research Organization or Medical Device industry experience or equivalent knowledge and experience.
- Experience in GCP Clinical trials;
- Excellent interpersonal, organization, communication, & influencing skills
- Experience managing complex projects and/or across global regions desirable;
- Good team player with global mindset;
- Ability to work independently and with rigor;
- Good process knowledge, experience, and skills
- Customer savvy and understanding of Clinical and Industry environment
- Experience in risk management
- Must be willing to travel as required;
- Prior experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook);
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
http://www.ukba.homeoffice.gov.uk/visas-immigration/working
Additional Eligibility Qualifications:
Desired Characteristics:
- Post graduate training / specialization in one of the following areas is desirable: Neurology, Cardiology, Radiology, Nuclear Medicine or Oncology, with industry experience;
- Experience in managing KOLs, external experts. Brings his/her own network of KOLs, external experts;
- Experience in scientific publications/communication.
Pass it on for Referral Bonus. Not the right role for you, but know someone we should meet? Share with him to earn $1,000 referral bonus.
Subscribe to us
100% Free.
close