First Hires in a Biotech Start-up: Who and When?

The first hires in a biotech company shape everything that follows: the culture, the quality of the data, the relationship with investors and how quickly you reach the next milestone. At the same time, the budget is tight, and every wrong hire costs more than in an established company.

Here is a practical guide to who you need, when you need them, and how to win candidates who could have chosen a safer job.

Hire for milestones, not an organisation chart

It is tempting to draw the organisation chart of a fully fledged pharmaceutical company and fill the boxes one by one. That is rarely wise. Ask instead: What must be in place for us to reach the next milestone – and which expertise do we not have today?

Typical milestones are:

Preclinical data confirming the mechanism of action.
Manufacture of trial material in line with GMP.
A clinical trial application and its approval.
The first patient enrolled in a clinical trial.
Data that can be used in the next funding round or a partnership.

Each milestone requires different expertise. Hiring in the right order avoids both bottlenecks and expensive employees without tasks.

The roles, phase by phase

Research and preclinical

The first phase is dominated by scientists with deep knowledge of the technology. Over time, experience in managing external vendors is also needed, because much preclinical work is outsourced to CROs. A senior scientist or project manager with industry experience can be an important early hire.

CMC and manufacturing

This is the role many hire too late. Manufacturing trial material takes time, is often outsourced to a CDMO, and requires someone who can manage process development, tech transfer and documentation. A Head of CMC or CMC lead should ideally be in place well before you need the material.

Quality

When you manufacture or import medicinal products for clinical trials, there are requirements for a quality system and for a Qualified Person to certify the batches. Many small companies start with a consultant, but eventually need in-house QA expertise. Read more about recruiting QA and QPs.

Regulatory

The regulatory strategy should be set early, for example for the first clinical trial application under the EU Clinical Trials Regulation (CTR). A regulatory adviser, employed or contracted, often saves both time and money.

Clinical Operations

As the first trial approaches, you need a Clinical Project Manager who can select and manage the CRO, sites and vendors. See our article on recruiting for clinical trials.

Leadership

As the company grows, leadership needs change. A founder with a strong research background often needs a CEO, CMO or COO with experience of clinical development and financing. Many companies also strengthen the board with industry experience before hiring into management.

Employee, consultant or partner?

Not every role needs to be a permanent position from day one:

Consultants or part-time roles suit needs that are clear but limited – for example regulatory strategy or the QP function in an early phase.
CROs and CDMOs provide access to capacity and facilities, but require someone in-house to manage them.
Permanent hires should be prioritised where the expertise is at the core of the company, or where continuity is essential.

A good rule of thumb: the expertise that creates the value and manages the vendors should sit in-house.

What makes candidates choose a start-up?

Experienced candidates from larger companies often have a secure job, good pay and good pension schemes. What makes them move is rarely the terms alone:

The chance to make an impact – on both the product and the company.
Scientific quality – a strong scientific foundation and talented colleagues.
Ownership – many start-ups offer share options or other ownership schemes.
Honesty about risk – candidates want to know how long the company is funded, and what happens if a milestone is missed.

Be open about funding and plans. It builds trust, and it filters out candidates who cannot handle the uncertainty.

Common mistakes

Hiring a "big pharma profile" without hands-on experience. In a small company everyone also has to do the work themselves.
Hiring CMC and quality too late. Manufacturing trial material is often the longest road to the first patient.
Unclear roles. When everyone does a bit of everything, important responsibilities fall between the cracks.
Underestimating the time. With a three-month notice period, the search must start long before you need the person.

How Oslo Life Sciences can help

Oslo Life Sciences helps biotech companies find their first key people – from scientists and CMC leads to quality, regulatory, clinical and leadership. We can also provide market insight into salary levels and available talent before you decide which role to fill first. Because we search in Norway, the Nordics and DACH, we can find candidates with experience from mature biotech communities in Europe.

Read also about executive search and headhunting – often the best way to reach candidates who are not looking.

Frequently asked questions

When should we hire a Head of CMC?

Ideally before you have chosen a CDMO and started process development for trial material. Many companies discover too late that CMC is the longest road to the first clinical trial.

It is common in start-ups and can be an important argument for candidates giving up a secure job. The design should be clarified with legal and financial advisers.

Can we afford a recruitment agency?

For the most important key roles, the cost of a wrong hire or a delayed milestone is often higher than the fee. Read more about recruitment agency fees.

Should we hire in Norway or abroad?

It depends on the role. For many specialist roles the Norwegian candidate market is small, and it can pay to search in the Nordics and the DACH region.