Five capabilities that matter in a first General Counsel hire for life sciences
Key insights
- Life sciences businesses typically need legal support across five core areas: regulatory affairs, clinical trials, intellectual property, commercial contracting and healthcare compliance
- Regulatory expertise becomes increasingly important as companies approach approvals, commercial milestones and expansion into new markets
- Commercial and supply chain contracting becomes more important as businesses move towards commercialisation
- The strongest hiring briefs prioritise the two or three capabilities most closely linked to near‑term business risk
When a life sciences or pharmaceutical business is ready to make its first senior legal appointment, our in-house legal recruitment team helps leaders define the capabilities the role must cover before they go to market.
A funding round, clinical milestone, licensing agreement or move towards commercialisation can all create pressure to bring legal expertise in-house. The challenge is not simply deciding whether to hire a General Counsel. It is understanding what that person needs to be able to do.
The strongest briefs start with the legal risks facing the business now and over its next stage of growth. In life sciences and pharmaceuticals, those risks usually sit across five connected areas. Few candidates will offer equal strength in all of them, so the priority is to identify which capabilities matter most.
“We know we need legal support. But what kind of lawyer do we actually need?”
Why the capability mix matters
Life sciences organisations operate at the intersection of science, regulation and commerce. A first General Counsel may need to support product development, clinical activity, intellectual property, partnerships, supply arrangements and healthcare compliance, often while establishing the legal function itself.
That makes a generic General Counsel job description a weak starting point. The right brief should reflect the organisation’s development stage, operating markets and upcoming milestones. It should also distinguish work that needs to move in-house from work that can remain with specialist external advisers.
1. Regulatory affairs and product approval
A first General Counsel does not need to replace the regulatory affairs team. They do, however, need to understand how legal risk connects with clinical timelines, approval pathways and commercial decisions. Experience working alongside bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) or US Food and Drug Administration (FDA) may be particularly relevant for businesses operating across several markets.
- How dependent is the next stage of growth on a regulatory submission or approval?
- Will the lawyer need to coordinate decisions across the UK, EU and US?
- Where could a legal issue delay a clinical or commercial milestone?
The answers help determine whether regulatory experience should be a core selection criterion or a capability that can be supported externally.
2. Clinical trial agreements and research collaborations
Clinical development creates important relationships with contract research organisations (CROs), investigator sites, academic institutions and commercial partners. Those arrangements can involve patient data, consent, intellectual property ownership, liability and publication rights.
- The volume and complexity of active clinical studies
- The number of research partners and jurisdictions involved
- Whether contracting delays are affecting operational teams
- How consistently legal positions are applied across agreements
For an organisation with multiple studies or collaborations, hands-on clinical contracting experience may be essential. For an earlier-stage business with limited activity, strong commercial judgement and effective management of specialist counsel may be enough.
3. Intellectual property strategy
Intellectual property is often central to the value of a life sciences business. Patent strategy, licensing arrangements, research collaborations and freedom-to-operate analysis can influence investment, partnerships and long-term commercial plans.
- How intellectual property supports the business model and investment story
- The commercial risks within licensing and collaboration agreements
- When patent attorneys or other specialist advisers are required
- How ownership and usage rights should be protected in partnerships
The goal is not to find a General Counsel who can replace every technical adviser. It is to appoint someone who can connect specialist advice with business priorities and make sure intellectual property risk is considered in commercial decisions.
4. Commercial and supply chain contracting
As a business moves towards commercialisation, its legal workload often shifts. Manufacturing, distribution, procurement and supply arrangements become more prominent, while entry into new markets adds contractual and regulatory complexity.
- Improve consistency across commercial agreements
- Set clear positions for recurring negotiations
- Support manufacturing and distribution relationships
- Create contracting processes that can scale as the business grows
This capability may carry more weight for a company preparing for launch than for one focused primarily on early research. The hiring brief should reflect the work the legal leader will face next, not only the work being managed today.
5. Healthcare compliance
Interactions with healthcare professionals, anti-bribery obligations, transparency requirements and restrictions on advertising and promotion can create significant legal and reputational exposure. A first General Counsel may need to advise commercial teams, improve policies and establish a practical route for escalating concerns.
- Will growth increase engagement with healthcare professionals?
- Is the organisation expanding into markets with different compliance requirements?
- Are third parties acting on the organisation’s behalf?
- Do commercial teams have clear guidance and approval processes?
If these issues are becoming more frequent, healthcare compliance experience should be visible in the brief rather than treated as a secondary requirement.
Prioritise the risks, not an impossible wish list
Very few candidates will bring the same level of experience across regulatory affairs, clinical trials, intellectual property, commercial contracting and healthcare compliance. Requiring equal strength in all five areas can narrow the candidate pool without improving the quality of the hire.
A more realistic approach is to identify the two or three capabilities linked to the organisation’s most important near-term risks. The General Counsel can then manage the remaining gaps through external counsel, interim support or future hires.
This prioritisation also makes assessment more useful. Interview questions and case studies can focus on situations the successful candidate is likely to face, rather than testing knowledge that may have little bearing on the role.
Start with a legal risk map
Before writing the job description, map how legal work is currently handled. Look at the issues taking the most management time, the areas generating external legal spend, the upcoming milestones that carry the greatest legal complexity and the consequences if advice arrives too late.
This exercise should shape the role’s remit, seniority and reporting line. Our guide to hiring your first in-house lawyer provides a broader framework for deciding between a General Counsel, Head of Legal or another first legal hire, as well as considering interim options.
Build the brief around the next stage of growth
A successful first General Counsel hire in life sciences is not about finding one lawyer who can cover every legal discipline. It is about understanding where legal risk sits, deciding which capabilities need to be owned in-house and appointing a leader who can manage the rest intelligently.
Begin with the business milestones ahead. Then rank the five capability areas against the impact each one could have on those plans. That gives leadership teams a clearer brief, a more relevant candidate pool and a stronger basis for assessment.
Frequently asked questions
Most life sciences companies begin considering a General Counsel when legal risk starts influencing strategic decisions, such as funding rounds, clinical trial activity, licensing deals, regulatory submissions or commercialisation plans.
The ideal profile depends on the company’s stage of growth. Early-stage businesses may prioritise intellectual property, fundraising and licensing experience, while later-stage organisations often need expertise in regulatory affairs, commercial contracting, healthcare compliance and market expansion.
Not necessarily. While an understanding of regulatory risk is important, many companies can continue to rely on specialist external advisers for technical regulatory matters. The key is hiring someone who can connect regulatory advice to business decisions and manage legal risk effectively.
The answer depends on legal complexity rather than company size alone. Businesses with significant regulatory exposure, multiple stakeholders or strategic legal decision-making needs may benefit from a General Counsel, while others may initially be better served by a Head of Legal or experienced commercial lawyer.
One of the most common mistakes is creating a wish list that requires expertise across every legal discipline. The strongest hiring briefs focus on the two or three legal capabilities most closely linked to the company’s near-term risks and growth plans, rather than seeking a candidate who can do everything.
