Regulatory CMC Director ** Cell Therapies Lifecycle ** Manage 2+ people** Grow your team, grow your career! US East Coast NYC, NJ or MA or Semi Remote

Reference: SMM509A

Expiry Date: 01-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
New York County
Съединени щати

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Job Description

Why would you consider this role?

  • You manage a matrix team or a small team of 2 or more FTEs, and now want to be in a role where you can grow your team, and develop your senior leadership skills for future development
  • You want to be the “go to key person” for CAR-T lifecycle, working with commercial and development teams, internal development experts (for devices) and the therapy regulatory teams
  • You want to work in a big pharma with 2 existing, highly successful CAR-T products, which has the biggest pipeline in industry for CAR-Ts
  • You will have expertise in preparing for HA meetings, managing responses to HA queries as well as mitigation planning
  • You want to work in a global role, supporting global lifecycle on one of these two existing products in a company which has follow on drugs in Ph1/2 and is not short on money, GMP manufacturing is inhouse!
  • You want to be visible, have acknowledgement and visibility for you and your teams’ successes, in a company which is on the leading edge of oncology treatment

What my client is looking for?

  • You will have development experience on Cell or Gene Therapies, and prior lifecycle experience on mAbs or advanced recombinants; in this role you will combine earlier mAb lifecycle expertise with your current Cell & Gene Therapy
  • You will be passionate about people, know how to develop people in Regulatory CMC up the skills and confidence ladders
  • You will know how to manage expectations of the stakeholders in US and EU, in team, which is very diverse and multi-cultural, on any metric

What my client is giving in return?

  • An upper end basic salary reserved for individuals with this type of expertise, plus decent bonus level, annual and sign on RSUs for the right person
  • My client will buyout losses and also provide a Cadillac relocation if needed
  • The role comes with a good health insurance, savings and PTO is better than average.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore on US 908 348 6714, or send a full CV to theo@advtalent.com and I would be happy to discuss the role further and give you more information. As I know the hiring manager, I will support you throughout the interview and on-boarding experience.

If this role isn’t quite for you but you are open to something new, I would welcome to discuss other roles we have open in the Cell and Gene therapy space.

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