Executive Regulatory Director CoDxs & DigiMeds Head - Oncology & Precision Meds

Job Description
Executive Regulatory Director CoDxs & DigiMeds Head - Oncology & Precision Meds NJ/NYC/PA

Note: My client offers Digital Hiring and On-Boarding using Video Conferencing and the successful candidate will be inducted and trained remotely. Applicants are invited from the USA, mainland Europe and Switzerland if you are willing to work from one of two sites in the NJ area (one is close to NYC, one is PA/NJ borders).

During the next period, new hires will be allowed to work from home full-time, until such time when normal working returns.

About my Client

This role is for a leading Top 10 pharmaceutical company, with a strong portfolio and pipeline of mAb, NCEs, Cell / Gene Therapies across multiple therapeutic areas including Oncology.

This is a luminary role, you will shine a light on what CODxs and Digital Medicines can deliver to the clinic, and to the patients, and manage an expanding team which will support combination DigiMeds and complimentary / companion IVDs (CODx's). The role encompasses both people management, program management and developing global / regional initiatives. It is regulatory authority facing.

About the Role

This is a global leadership role in regulatory, so you will lead the strategists as well as develop the platform, to enable highly effective CODx development parallel to drug development, by effective partnering with the Precision Meds group, the therapy side Global and Regional Regulatory Liaisons, their Therapy Regulatory Heads, as well as with the vendors, especially in Oncology, and in an organization which has highly adaptive pathways in play for their assets in clinical development, so agility is also important.

You will build the team and the platform, developing the design space and regulatory / innovation thinking, through engagement with stakeholders, as well as working to develop the space with regulators to garner buy-in to new thinking, explain strategy, and ensure robust RA strategies are supported by the regulators.

The role reports to a seasoned VP, who is very considered, capable, has a strong track record in both people management and regulatory filings for major products. You will be given the opportunity to develop in this role over time, in terms of grading and responsibility, based on merit and deliverables.

Your Background & Experience

You will have your own regulatory track record and be able to demonstrate in your career thus far how successfully you have provided strategic input on key development plans and submissions in parallel with CODx's / NMEs development: INDs, IDEs, SRDs, PMAs, CE Marked, ideally in Oncology.

You will have managed teams of direct reports or large matrices, ideally of >8 FTEs, and have significant experience in developing people. You will have a personality which lends itself readily to collaboration, is motivating to peers, teams and strategists, developing strong key relationships.

My Client Offers in Return

A red carpet relocation including house purchase / sale, generous disturbance allowances, and support for co-location in the short or medium term.

Annually, this package befits the grade, you will benefit from a strong annual stock award with a quicker vesting period, a highly competitive salary and performance bonus which has good multipliers on a personal and company performance level.

The company will buy out stock and 2020 bonuses as part of an offer.