Global Medical Director - Pharmacovigilance / Drug Safety / Late Stage Clinical Development
A Global pharma is looking for someone with a strong background in late stage clinical trials to help their growing pipeline.
Oncology, rare disease, cardiovascular and many more - this is a great position for someone who is looking for an adventure.
You will be required to run trials in countries across Asia, report the results and success in each country to the Head of Science (in Japan and America) and continue to support the Pharma company in both a Regional and Local focus.
People with a drug safety, Pharmacovigilance, Epidemiology or Late stage clinical development background are all welcome.
As a Senior Medical Director of Clinical Development you will be responsible for;
- The late stage drug development phase of multiple indications across Asia with a focus in (but not limited to) patient safety, trial design, pharmacovigilance and clinical development.
- Supporting the Medical and Commercial teams during launches of key drugs across the Asia region.
- Design and develop the clinical strategy for multiple late stage compounds alongside the global team.
- Travel to Asian markets and research sites and engage with KOLs, attend conferences and speak with other local team members (10 - 20% travel maximum).
- Responsible for budget maintenance and allocating funds according to research results, strategy and company decisions.
- With the team select and engage key clinical study sites/centers and establish and maintain collaborative relationships with key investigators.
- Working with the major Asian regulatory bodies and championing the company across the Asian region.
- Ensure that Clinical Development Standard Operating Procedures (SOPs) facilitate the development of effective clinical study protocols and are compliant.
- Develop/review/edit essential study documents such as protocols, medical monitoring plan, and medical data reviewing plan, case report forms, database specifications, and statistical analysis plan.
- Provide medical input in all essential documents, including, investigator brochure, clinical study reports, IND and NDA summary documents safety annual reports.
As a clinical development project lead you will need;
- M.D or equivalent (essential)
- Current or previous work in Late stage drug development (essential), this can be Clinical Development (Phase III), Drug Safety, Real World Evidence, Non-interventional Studies and/or Pharmacovigilance.
- Ideally previous work within multiple different disease fields. (preferred not essential)
- Ideally previous work at a regional level or Asian countries. (preferred not essential)
- English fluent -(essential).
Package:
- Competitive salary.
- 80% Accommodation paid for + relocation support + Visa support.
- Flexible working - home office work available.
- Friendly office space, coffee, tea, social events - it is also a Global HQ so very international.
- Child and Pension support.
- Subsidised and delicious Japanese food in the canteen (their words not mine ;)
- Travel coordinator provided for all business trips.
- Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
Next steps:
If you are interested in this mission, or in general would like to discuss your options in Asia then please send me your CV, apply on LinkedIn and contact me.
This is what the process will look like:
- Full call with the executive recruiter responsible.
- Sharing of the company and confirmation by you to move forward.
- Introductory call with the HR BP and Hiring Manager (two calls, normally on the same day).
- Panel Interview.
- Final call with senior stakeholders.
- Offer.
Note: Coronavirus, like the current British weather, is always changing and caused many things to become unpredictable, the above is an outline but could change.
My contact details
/ 0044 203 758 8923 /
https://www.linkedin.com/in/charles-spence-epm/
This will be confidential and your CV will not be shared to anyone without your permission.
Please apply today or reach out confidentially.
Keywords
Medical Director - Pharmacovigilance - Drug Safety - Real World Evidence - Non interventional - Real World Insights - Clinical Development - Trial Design - Protocol Management - Study Protocol - Medical Affairs - Clinical Research - Osaka - Japan - Asia - Asian - Regional - Head - Director - Global - Phase III - Phase 3 - Phase IV - Phase 4
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