Expiry Date: 14-11-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
NEW - Associate Director or Director CDx Regulatory
About My Client
This is a role with a Top 5 global pharmaceutical company which occupies an exclusive niche position with a focus on novel products across with 4 major therapy areas and over 100 years' history and track record of bringing new medicines to market while having one of the most innovative pipeline in the industry currently. Their pipeline and this role includes oncology.
The team is managed by a considerate, capable and mindful Vice President, who is building up the team on two sides, with Oncology and Precision Meds for clinically useful biomarkers, and with their Digital Medicines for med ed, adherence, and other patient-centric innovations, this regulatory role is one of the key bridges between the Clinical Development, Therapy Regulatory and Precision Meds teams. What
I like about this role is, it is reporting to an ex-FDA Section Head, a well-known name, who has worked in industry after leaving the FDA and has an outstanding reputation for developing her staff and is a eulogist for ‘how CDx’s can transform patient treatment’.
About this Opportunity
Are you excited by a strategic role that allows you to drive and shape scientific innovation? In this role, graded as Associate Director or Director you will act as the CoDx RA strategist and a team member sitting alongside Global and US Regulatory Therapy Leads to support Oncology, Neuro, Immunology, Genetic and Cardio medicines development by developing the RA plans for the CDXs and / or accompanying Digital Medicines solutions with oversight for any necessary Regulatory submissions.
You will lead, coordinate and drive complicated Companion Diagnostics programs with the partners, for adaptive design Clinical Trials and quick changing oncology programs requiring Clin Trial Assays, ris, assessment and IDE filing. Although, you will work across all therapeutic areas.
The role is global and this is a great opportunity for an experienced CDx regulatory professional. You might have gained your regulatory experiences with a CDx/IVDs company, supporting Oncology development as a vendor or in-house with a Biotech or Biopharma, in order to steer and bridge the two-parallel development workstreams. Alternatively, you might be working with a Regulator and now want to come over to industry.
You will have already provided tactical and operational support as well as coordination of associated IVD submissions to the US FDA or other health authorities. You will be a capable communicator, able to work well in matrix teams, with your own accountabilities and deliverables.
You will want a career environment where stead progress is encouraged and understand the idea that development comes with merit and aptitude.
My Client Offers in Return
A high-end basic salary as well as a high-performing stock plan, bonus scheme and medical insurance with shorter vesting. A full relocation is available post-Covid, whether you own a house or rent one, and you can be hired and on-boarded at home in the meantime. My client will buyout a certain amount of stock or performance bonus!
To apply for this role, please press the red “Apply for position”, or contact Matt Greig on 855.505.1382. ADV Talent operates a Global Data Protection policy and will not forward your details without your written consent.
Note: My client offers Digital Hiring and On-Boarding using Video Conferencing and the successful candidate will be inducted and trained remotely. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns!
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