Director, Clinical trials and Partner Compliance

Om jobbet

About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.

Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.

iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:

Overview of Job Role

The Director, Clinical trials and Partner Compliance will be a high-impact leader, developing our Clinical trial management and Business Partners compliance infrastructure. This is a rare opportunity within a global biosimilar leader to build a specialized Clinical trial and compliance team from ground up with a strategic and lean approach using a state-of-the-art Safety database systems. You will be fully accountable for the integrity and strategy of all Clinical trial Safety activities for Alvotech Clinical trials and Business Partners and Compliance activities for the product lifecycle in post-marketing. This role is about building a lean and efficient team, defining the team's processes, owning the deliverables and ensuring regulatory compliance.

Scope and responsibility

• Recruit, mentor, and lead a high-performing Clinical trials and Compliance team, fostering a culture of scientific excellence and regulatory agility.

• Drive the strategy for Clinical trial safety activities and documents preparation and management (e.g. SMP, Protocol, eTMF, IB, etc.) for Alvotech Clinical trials

• Drive the strategy for Business partner relationships and Compliance monitoring in post-marketing (e.g. PV agreements, PV commitments, Business Partner support, Compliance monitoring, etc.)

• Business owner of Safety systems and processes to execute Clinical trials and Compliance team activities (SME), system setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.)

• Establish, maintain and optimize Global Pharmacovigilance system processes and ensure compliance with international law and regulations (e.g. FDA, EMA, ICH).

• Work cross-functionally with other PV department sub teams to align on resources, timelines and deliverables for Clinical documents preparations, PVAs and compliance monitoring activities and ensure execution and regulatory compliance.

• Work cross-functionally with other teams and departments in the company (e.g. Clinical development, Operations, Quality, Regulatory, Medical affairs, etc.)

• Works externally and supports Alvotech Business partners and PV service Providers

• Audits and Inspections deliverables related to Clinical trials and Compliance team activities

Job requirements

• Education: Master's Degree in pharmaceutical sciences or related fields - medicine, pharmacy, life sciences; advanced degree is preferred (e.g. PharmD., PhD.)

• Experience: 10+ years in Pharmacovigilance/Drug Safety with at least 5 years in a senior team leadership or supervisory role.

• Deep expertise in Clinical trials, Business partner compliance and Safety systems (e.g., Argus, ARISg); previous experience with Veeva Platform (e.g. Safety Vault/Safety Docs) is great advantage

• Proven track record of management of PV teams and global Product and Study portfolios

• Previous experience with biologic and combination products is an advantage

• Detailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)

• Mature self-organizational, time-management and interpersonal skills

• Excellent communication skills, maintains a positive, result oriented work environment

• Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.

• Willingness to travel internationally, as required

What we offer:

• Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people's lives.
• Global Growth: Join a fast-growing, international company with a diverse and inclusive culture.
• Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity.
• Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities.
• Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.
• Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.
• Community & Celebration: Participate in regular social events and celebrate team milestones together.