Associate Director/Director Study Lead

About us

GRANITE BIO is a private biotechnology company located in Basel (Switzerland).

GRANITE BIO is supported by top-tier investors with ~$100M raised to date. Based on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT-001, the lead asset, depletes inflammatory monocytes. It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic effect. The Phase 1b trial in patients with Ulcerative Colitis has just started. GRT-002 is an IL-3 neutralizing antibody that is thought to play an important role in type II inflammation.

Our company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills.

The Associate Director / Director Study Lead will provide strategic and operational leadership across all aspects of clinical trial execution, including study planning, CRO/vendor oversight, study conduct, risk management, and trial closeout activities. This role is accountable for ensuring the successful delivery of clinical studies in alignment with corporate objectives, timelines, budget, quality expectations, and regulatory requirements.
Reporting to the Head of Clinical Operations, the Associate Director / Director will play a critical leadership role within cross-functional study teams and will serve as a key operational partner internally and externally. The individual will ensure that clinical programs are executed efficiently and in compliance with SOPs, applicable regulations, CFR requirements, ICH-GCP standards, and global regulatory guidelines.
The successful candidate will be a highly collaborative and proactive clinical operations leader with strong strategic thinking, problem-solving capabilities, and the ability to influence across functions and external partnerships. The ideal candidate will demonstrate excellent organizational, communication, and leadership skills, with a strong focus on quality, innovation, operational excellence, and continuous improvement.

Responsibilities

• Provide strategic leadership and end-to-end operational oversight for global clinical trials from study start-up through database lock and closeout.
• Lead and manage relationships with CROs, vendors, and external partners, ensuring high-quality execution, performance oversight, and compliance with protocol requirements, SOPs, regulatory requirements, ICH-GCP guidelines, and quality standards.
• Serve as the operational study lead and primary point of accountability for clinical trial delivery, proactively driving timelines, quality, budget, and risk management.
• Oversee clinical trial budgets, forecasting, resource planning, vendor contracts, and invoice reconciliation to ensure financial accountability and operational efficiency.
• Provide strategic oversight and review of study documents, operational plans, and working procedures; ensure appropriate training and alignment of internal and external study teams.
• Drive study governance through proactive tracking of key milestones, KPIs, risks, and critical path activities, ensuring timely identification, escalation, and resolution of operational issues.
• Partner cross-functionally with Clinical Development, Medical Monitoring, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Quality Assurance, and other stakeholders to ensure alignment on study objectives, deliverables, and timelines.
• Ensure effective oversight of CROs and investigative sites to support timely, accurate, and inspection-ready clinical data and documentation.
• Provide leadership oversight of Trial Master File (TMF) quality, completeness, and inspection readiness throughout the study lifecycle.
• Chair clinical trial team meetings, governance forums, and vendor oversight meetings; drive decision-making, accountability, and communication across stakeholders.
• Lead ongoing clinical risk assessment activities and ensure implementation of appropriate mitigation and contingency strategies in alignment with the Quality Management System (QMS).
• Identify opportunities for operational excellence and drive implementation of innovative processes, technologies, and best practices to optimize trial execution and delivery.
• Contribute to departmental initiatives, process improvements, SOP development, inspection readiness activities, and organizational scaling efforts.
• Mentor and provide operational guidance to Clinical Trial Managers and junior Clinical Operations team members as appropriate

Qualifications

• Advanced scientific degree preferred (PharmD, PhD, MSc, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related discipline; Bachelor’s degree with significant relevant experience will also be considered.
• 8–12+ years of progressive experience in clinical operations within the biotechnology, pharmaceutical, or CRO industry, including substantial sponsor-side experience.
• Proven experience leading global or regional clinical trials across Phase I–III studies, with accountability for study execution, CRO oversight, timelines, budgets, and risk management.
• Demonstrated leadership experience as a Clinical Trial Lead, Study Lead, or equivalent role with increasing strategic and operational responsibilities.
• Strong expertise in CRO/vendor management, including performance oversight, governance, contracting support, and issue escalation/resolution.
• Deep understanding of ICH-GCP guidelines, FDA, EMA, and applicable global regulatory requirements, with demonstrated experience ensuring inspection readiness and quality compliance.
• Experience working in cross-functional matrix organizations and effectively influencing internal and external stakeholders at multiple organizational levels.
• Strong strategic thinking, analytical problem-solving, and decision-making capabilities, with the ability to manage complexity in a fast-paced environment.
• Excellent organizational and project management skills with proven ability to manage multiple priorities and deliver high-quality results within timelines and budget.
• Exceptional communication, presentation, and interpersonal skills, with the ability to lead meetings, drive alignment, and communicate effectively with senior leadership, vendors, and study teams.
• Experience in clinical risk management, quality oversight, and implementation of mitigation strategies throughout the clinical trial lifecycle.
• Demonstrated ability to drive process improvements, operational excellence initiatives, and innovative approaches to trial execution.
• Proficiency with clinical trial systems and tools including CTMS, eTMF platforms, and Microsoft Office applications (Word, Excel, PowerPoint).
• Previous experience in biologics and/or early-phase clinical development (Phase I/II) strongly preferred.
• Therapeutic area expertise in immunilogy preferred.
• Prior people management and/or mentoring experience is considered a strong advantage for Director-level candidates.

What we currently offer

Prime Location
Our modern laboratories and offices are located in Tech Park Basel – a leading hub for early-stage start-ups.
Commuter Benefits
We support your individual commuting needs with parking options or a commuter allowance.
Flexible Working
We offer flexible working arrangements where possible.
Additional Time Off
In addition to 24 days of annual leave, our offices and labs are closed between Christmas and New Year.
Your Birthday Off
Enjoy an extra day off to celebrate your birthday.
Coffee & Connection
Free coffee and a great space to connect with colleagues.
Personal Development
We support your professional and personal growth.
Creative Environment
Work in an innovative, dynamic, and creative setting.
Diverse Team
Join an international team of passionate and talented people.
Team Events
Regular off-site summer and winter events to connect and have fun together.