Business Development & Sales Manager

Company Overview

Holostem Srl is a pioneering biotechnology company specialising in Advanced Therapy Medicinal Products (ATMPs) and regenerative medicine. The company is best known for the development and commercialization of Holoclar®, the first stem cell–based ATMP to receive centralized marketing authorization from the European Medicines Agency (EMA).

Building on the success of Holoclar®, Holostem continues to advance innovative cell‑based therapies addressing severe unmet medical needs, working closely with treatment centres, regulators, and scientific partners across Europe and internationally.

Holostem s.r.l. website
www.holostem.com

Location

Italy (with extensive European and international travel)

Reporting Line

Chief Operating Officer (COO)

Role Purpose

The Business Development & Sales Manager will drive commercial growth and strategic expansion for Holostem’s ATMP portfolio, including Holoclar® and pipeline assets. The role combines business development, sales execution, and strategic partnership development, with a strong focus on treatment centre engagement, market access, and regulatory‑aware commercialisation models specific to ATMPs.

The successful candidate will act as a key interface between commercial strategy and operational delivery, leveraging Holostem’s experience with Holoclar® as a benchmark for excellence in ATMP market access, supply coordination, and stakeholder engagement.

Key Responsibilities

Commercial & Business Development

• Implement business development and commercial strategies as agreed with the Chief Operating Officer, building on the proven commercialization framework established with Holoclar®.
• Drive sales performance in assigned territories, supporting adoption of Holostem therapies at authorised and emerging treatment centres.
• Identify, qualify, and onboard new treatment centres, ensuring readiness in line with ATMP regulatory and operational requirements.
• Define, negotiate, and maintain supply and commercial agreements with treatment centres, reflecting the controlled supply and traceability models required for products such as Holoclar®.
• Ensure accurate forecasting and demand planning, aligned with manufacturing capacity and clinical scheduling.

Strategic Growth & Market Expansion

• Identify and evaluate strategic growth opportunities across European and selected international markets, including:
• Partnerships and institutional collaborations
• Licensing and co‑development opportunities
• Distribution and access models tailored to ATMPs
• Scout and analyse regulatory, competitive, and reimbursement environments, using the Holoclar® experience as a reference point for risk mitigation and opportunity assessment.
• Propose and implement market‑specific strategies that support sustainable expansion while maintaining compliance with EMA and national frameworks.

Stakeholder & Relationship Management

• Build and maintain strong relationships with key stakeholders at treatment centres, including clinicians, surgeons, pharmacists, procurement teams, and hospital management.
• Act as a trusted commercial and scientific partner, supporting appropriate patient access to Holoclar® and future therapies.
• Ensure consistent engagement with key opinion leaders (KOLs) in regenerative medicine and ATMPs.

Cross‑Functional Collaboration

• Collaborate closely with Scientific, Regulatory, Quality, Client Services, Manufacturing, Clinical, Supply Chain, and Finance teams to:
• Align commercial opportunities with operational and manufacturing readiness
• Support regulatory compliance and post‑authorization commitments linked to Holoclar®
• Ensure timely, compliant delivery of therapies to treatment centres
• Support internal decision‑making with market insights derived from field activities.

External Representation

• Represent Holostem at international conferences, scientific congresses, partnering events, and investor meetings, positioning Holoclar® as a reference ATMP success story.
• Increase company visibility and generate qualified commercial and strategic leads across Europe and beyond.

Qualifications & Experience

Education

• PhD in Life Sciences or a relevant scientific discipline (required).
• MBA or equivalent business education is a plus but not mandatory.

Professional Experience

• Proven experience in business development, sales, or strategic consultancy within biotech, pharma, or advanced therapies.
• Direct experience with ATMPs, regenerative medicine, stem cell or cell‑based therapies; familiarity with Holoclar® or similar hospital‑based ATMP models is a strong advantage.
• Solid understanding of the EMA regulatory framework, including centralized authorization and post‑marketing obligations.

Technical & Business Skills

• Knowledge of pharmaceutical and ATMP operations, including manufacturing‑commercial interfaces.
• Experience with forecasting, contract negotiation, and partnership structuring.
• Ability to assess complex regulatory and market environments and translate insights into actionable commercial strategies.
• Basic computer literacy; experience with CRM and reporting tools preferred.

Language Requirements

• Fluent written and spoken English (mandatory).
• Fluent written and spoken Italian (mandatory).
• Additional European languages are a plus.

Personal Attributes

• Strategic yet hands‑on mindset, comfortable operating in a high‑innovation, regulated ATMP environment.
• Strong interpersonal and negotiation skills, with the ability to engage credibly with scientific, clinical, and executive stakeholders.
• High level of autonomy, resilience, and willingness to travel extensively.
• Strong ethical standards and commitment to patient‑centric commercialisation.

What Holostem Offers

• A pivotal role in a company with a landmark ATMP success story (Holoclar®) and an expanding pipeline.
• Exposure to cutting‑edge regenerative medicine and advanced cell‑based therapies.
• Direct interaction with senior leadership and influence on commercial and corporate strategy.
• Competitive compensation package aligned with experience and performance.

Privacy
Privacy Policy - Holostem S.r.l.

Application
Application must be submitted by the 10th May 2026 to the following link: https://apply.workable.com/
The position is open to both genders (L.903/77 – D.Lgs. n.198/2006)