Associate Director or Director CMC Drug-Device Combinations (AIs) ** MA, USA or REMOTE (Code USA 100921-4)

Reference: MG100921C

Expiry Date: 10-11-2021

Categories Biotech, Pharmacy, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

Associate Director or Director CMC Drug-Device Combinations (AIs) ** MA, USA or REMOTE

About My Client

My client is a well-known and highly successful biotech with <> 10 high value drugs in market, and a significant size of T/O at approx. $15 Billion (the company generates 2-4 times as much value per employee than the average of the top 10 R&D Bio-tech companies). The organization are known for their science and I mean their ability to translate research and discovery into the successful development of new innovative medicines. They organize across multiple modalities, using successfully shared technology platforms, whether this is in manufacturing, or as it pertains to this role, for shared injectors and smart devices used across more than one drug in more than one treatment.

Covid Note

My client will consider hybrid working for experienced individuals or possibly remote working.

The company will allow some home / office based on your experience, or fund a full relocation to one of these 2 sites. If you are willing to consider remote working, you are funded for travelling to the office 2-3 times a quarter. My client might ask you to observe Eastern Standard time as working hours.

The Role

Depending upon your experience of managing people, you will have oversight for either a workstream or the workstream and the headcount. Either way you will grow into a people manager, but not in a traditional way, but as someone who coaches and mentors your team, develops the relationships with stakeholders to keep the glitches and risks under review, as well as help your team operation in a global matrix by supporting the individuals' accountability and visibility. You will manage risks up and down the organization.

You will provide leadership for a workstream, for multiple drug-device combinations either in development or in marketed lifecycle, including some very high profile brands or development assets. You will know how to manage an extended enterprise, i.e. Contract Manufacturers, with the normal US, EU and international diversity in regulatory pathways, e.g., CE Marked in the EU Vs parallel drug and device filings in other markets.

The line manager and leadership team speak with one voice and are clear on doing everything necessary to enhance the reputation and value given by the group, in a company where there is a healthy relationship between manufacturing, QA and CMC Regulatory, as well as with the technical and program leadership teams and therapy regulatory. You will not be joining a rickety ship.

You will provide oversight and support for the workstream for HA interactions, working with partners to resolve any potential risks or hold-ups as proactively possible.

The Package

The role can be graded based on your existing people management experience as either Associate Director for matrix experience only, or Director if you have directly managed bigger groups. The packages are commensurate with this idea and include 20-25% bonus, stock plans with quick vesting, high end salary, and relocation if needed or desired.

To Apply!

Please contact me, Matt Greig, for this role by email to matt@advtalent.com or if you would like more information on the role, on 908-332-9157 (including Saturday and Sunday AMs). I will support you throughout the interview and on-boarding experience.

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