Industries · Healthcare & Life Sciences
Cell and Gene Therapy Legal Recruitment
A company with an advanced therapy in the clinic is running a filing calendar. The in-house hire is the person who owns the join between that calendar, the manufacturing file and the license — not a generalist life-sciences lawyer with a regulatory interest.
The calendar has an owner for every line, and none for the join.
Cell and gene therapy companies hire ATMP regulatory affairs counsel, licensing counsel and manufacturing counsel because the Joint Clinical Assessment, the Clinical Trials Regulation and the FDA product list now run on dated calendars. We staff those seats for developers and contract manufacturers; a copied biotech GC description is the usual failed brief.
- What ATMP means
- Under Regulation (EC) 1394/2007: a gene therapy medicine, a somatic-cell therapy medicine or a tissue-engineered medicine, plus a combined class that incorporates a device.
- US product stock
- FDA publishes the approved cellular and gene therapy list. Approval is not the end of the legal file.
- Europe's join date
- 12 January 2025 for the Joint Clinical Assessment on new cancer medicines and ATMPs; 30 January 2025 for the Clinical Trials Regulation transition close.
- Team size
- Listed medtech and life-sciences legal teams run 8–20 lawyers at median. A clinical-stage developer is often still at 1–4.
- Sartori book
- 230+ in-house placements since 2017, including 38 GC/CLO and 41 compliance-leadership seats, 23 countries.
This is not a restatement of pharmaceuticals or biotechnology. Those micros still hold for IP, financings and classical small-molecule work. The ATMP developer is running a different instrument: comparability after every process change, a Joint Clinical Assessment that applies from a date, and a manufacturing appendix that is the license. The market note that sits behind this page is cell and gene therapy regulatory counsel. Licensing mechanics that are not ATMP-specific live on life-sciences licensing and collaboration counsel.
Companies come to us when a filing date has been set and legal is still a panel of outside counsel. That is a retained search, not a secondment. Offer acceptance on the corporate book is 96%. GC and CLO searches carry a 12-month replacement term in the letter. How a company should think about the first legal hire is in hiring your first general counsel and building in-house legal teams.
Legal leadership companies hire here.
Six seats. Each card is a company service, not a law-firm practice group.
General counsel, clinical-stage ATMP developer
Often the first lawyer. Owns financings, partnering, board papers and the join between regulatory affairs and the BLA or MAA calendar. Reports to the CEO. A listed-company GC job description copied onto a 40-person developer is the usual mistake.
First general counsel search 02ATMP regulatory affairs counsel
The seat the filing date creates. FDA Office of Therapeutic Products, EMA ATMP classification under Regulation (EC) 1394/2007, MHRA, and the Joint Clinical Assessment from 12 January 2025. A policy author who has never owned a submission is the wrong profile.
In-house counsel recruiting 03Licensing and collaboration counsel
Structures option, license and milestone agreements with larger pharmaceutical counterparties. The work is the same family as the licensing desk we write about separately; here the asset is an ATMP and the manufacturing appendix is the deal.
In-house counsel recruiting 04Manufacturing and CMC counsel
Comparability after a process change, CDMO contracts, and the file three functions edit and none own. Contract manufacturers with a Massachusetts or EU site hire this seat when a sponsor's auditor starts asking who signed the change.
In-house counsel recruiting 05Chief compliance officer
Promotional compliance, sunshine and, once a product is marketed, the pharmacovigilance join. Audit-committee reporting line. Of 41 compliance-leadership placements since 2017, the life-sciences briefs are the ones that fail when the JD is treated as optional without saying so in the letter.
Chief compliance officer search 06Deputy GC / Head of Legal
The second chair as the developer crosses from one asset to a pipeline. Splits commercial and regulatory so the GC can stay with the board and the next financing. Of 47 deputy and Head of Legal placements since 2017.
Deputy GC searchThree dates a hiring committee can put in a scorecard.
The FDA stock tells you the market is no longer preclinical. The two European dates tell you the calendar is no longer national.
- FDA list
- FDA publishes the approved cellular and gene therapy products list. Each marketed product carries a comparability, pharmacovigilance and labelling file that does not close when the BLA is stamped.
- U.S. Food and Drug Administration, approved cellular and gene therapy products
- 12 Jan 2025
- Date the EU Joint Clinical Assessment began to apply to new cancer medicines and to advanced therapy medicinal products — the first two categories in scope. Filing calendars in Europe now have a joint-assessment owner, or they have a gap.
- European Commission, Joint Clinical Assessment implementation page (2025)
- 30 Jan 2025
- Close of the Clinical Trials Regulation transition. From 31 January 2025 every legacy Directive trial still running had to comply and be recorded in CTIS. The legal work is the join between the trial file, the JCA and the manufacturing comparability package.
- European Medicines Agency; euclinicaltrials.eu (2025)
| Date | Instrument | What it does to the in-house seat |
|---|---|---|
| 12 Jan 2025 | EU Joint Clinical Assessment applies to ATMPs and new cancer medicines | Someone inside the company must own the JCA file |
| 30–31 Jan 2025 | Clinical Trials Regulation transition closed; legacy trials into CTIS | Trial-file counsel, not a policy author |
| FDA approved-product list | Standing Office of Therapeutic Products list | Post-market and comparability work on a marketed stock |
Source: European Commission JCA implementation page; EMA / euclinicaltrials.eu; FDA Office of Therapeutic Products.
Primary sources on this page
4 references- FDA — Approved Cellular and Gene Therapy Products fda.gov ↗
- European Commission — Joint Clinical Assessments health.ec.europa.eu ↗
- EMA — Advanced therapy medicinal products overview ema.europa.eu ↗
- EMA — Clinical Trials Regulation ema.europa.eu ↗
A retained ATMP search is a calendar, not a database send.
- Week 1 Mandate Blueprint
Filing date, manufacturing geography, reporting line, JD versus non-JD for any CCO, 12-month replacement in the letter.
- Weeks 1–2 Total-market mapping
Developers, CDMOs and in-house regulatory seats in Boston, London and the EU manufacturing belt. Blind both ways.
- Weeks 2–4 Private outreach
Approach against the submission history, not against a RAPS certificate. Shortlist with assessment dossiers.
- Weeks 5–9 Interviews and offer
Senior counsel median 8 weeks to accepted offer; CCO 10 weeks; GC/CLO 11 weeks (range 8–16).
Client reference
The shortlist arrived in just over three weeks and every name could already sit with our board. The person we hired is still in post two years later.
Compliance talent more broadly is covered in compliance talent acquisition. The research programme, including the Boston interview cohort, is at the research programme.
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Hiring ATMP counsel — questions from GCs and CHROs
Is cell and gene therapy legal hiring the same as a biotech GC search?
No. The scarce seat is ATMP regulatory affairs counsel who has owned a filing, not a generalist biotech GC. Generic biotechnology hiring still matters for IP and financings; it does not cover the Joint Clinical Assessment or a comparability file. Read cell and gene therapy regulatory counsel.
When should a clinical-stage developer hire its first general counsel?
When the filing calendar has a date and no single owner. Series B–C, a first regulated product, or a US/EU dual filing are the usual triggers. Fractional cover can hold two quarters; see first general counsel search and hiring your first general counsel.
Does the Chief Compliance Officer need to be a lawyer?
Not always, but the audit committee must say so in the brief. Life-sciences CCO searches that hide the JD question waste a month. We run the seat through chief compliance officer search, with the parent at compliance recruitment.
Where do you run cell and gene therapy searches?
Boston first, then London, New York and EU manufacturing sites. City pages: in-house recruiting in Boston, compliance recruiting in Boston, London and New York.
How long does a retained ATMP regulatory-counsel search take?
Senior counsel shortlist in 18 days; accepted offer in 8 weeks, of 96 specialist in-house placements since 2017. CCO searches run 21 days to shortlist and 10 weeks to accepted offer, of 41 compliance-leadership placements.
What do you need in the mandate letter before outreach?
The filing date, the manufacturing geography, whether the CCO reports to the audit committee, and the 12-month replacement term. Fee, off-limits and the replacement window go in writing before anyone is called. See methodology.
Start a conversation
Put an owner on the filing calendar.
Retained for GC, CLO and CCO searches. Fixed fee, three instalments, 12-month replacement. We map against submission history and manufacturing geography — not against a life-sciences mailing list.