About the Role
Biogen is seeking an Associate Clinical Country & Site Lead to join its team in Riyadh, Saudi Arabia. This role is focused on country-level clinical operations and requires local operational and scientific knowledge to support the clinical development strategy. The position is key to fostering local partnerships, improving customer satisfaction, and ensuring the focused delivery and execution of Biogen’s development pipeline.
Key Responsibilities
Working in close collaboration with the Director, Clinical Country & Site Lead, and the in-country Clinical Country & Site Lead or Senior Clinical Country & Site Lead, you will provide study teams with detailed local operational and scientific insights to ensure effective clinical operations execution. This involves integrating local opportunities, needs, and insights into operational plans. You will serve as a primary point of contact for investigators, affiliate office staff, CRO staff, and global teams, with a strong emphasis on quality, patient safety, and the oversight of CRO activities and performance. The role also includes acting as a site escalation point for investigator concerns, including issues related to data integrity, data quality, patient safety, or matters unresolved by the CRO, ensuring these are communicated to the appropriate Biogen responsible party.
- Maintain current local knowledge of Biogen’s therapeutic areas, standards of care, clinical trial requirements, and the needs of local investigators and research sites.
- Develop and maintain strong relationships with investigators and sites to position Biogen as a preferred partner for clinical research.
- Support country and site selection processes by gathering local insights and feedback from investigators and other key stakeholders.
- Act as the primary country-level QSDO/Biogen contact for sponsor oversight activities, including Sponsor Oversight Visits (SOVs), audits, inspections, and CRO oversight.
- Conduct co-monitoring activities during Sponsor Oversight Visits, verifying that trial records, informed consent documentation, and source documents are maintained in accordance with protocol, ICH-GCP, SOPs, and local regulations.
- Lead interactions with investigators, affiliate teams, CRO staff, and global stakeholders to facilitate information exchange and timely issue resolution across clinical studies.
- Monitor and assess overall trial and country performance to support QSDO objectives and country-level goals.
- Contribute to local projects and broader Clinical Study Operations activities as a representative of the country.
Qualifications and Requirements
- A university degree or an equivalent combination of education with a science background and relevant experience is required.
- A minimum of 5 years of clinical research experience is necessary. Experience managing clinical trial activities is desirable, particularly sponsor oversight activities in an outsourced / FSP model with CROs/vendors.
- A strong understanding of the cross-functional drug development process and significant scientific/clinical knowledge across key therapeutic areas is essential for discussing compounds, development plans, and protocol endpoints with investigator site personnel.
- Familiarity with ICH/GCP, applicable country regulations, and clinical trial monitoring in an outsourced model is required.
- Proven ability to manage a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities.
Required Skills
- Clinical operations expertise.
- Strong scientific and clinical knowledge.
- Proficiency in building and managing partnerships.
- Commitment to customer satisfaction.
- Experience in clinical trial execution.
- Excellent investigator relations skills.
- Proficiency in quality management and patient safety protocols.
- Experience with CRO oversight.
- Knowledge of data integrity and data quality principles.
- Expertise in relevant therapeutic areas and standards of care.
- Understanding of clinical trial requirements.
- Exceptional relationship-building skills.
- Sound judgment and proactive problem-solving abilities.
- Adaptability and ability to manage multiple priorities.
- Knowledge of ICH/GCP guidelines and country regulations.
- Experience in clinical trial monitoring.
- Strong organizational and project management skills.
- Effective working knowledge of relevant IT tools for virtual team working.
- Excellent knowledge of clinical operational activities and challenges across the local geography.
- Strong interpersonal skills, cultural awareness, and high emotional intelligence.
- Collaborative decision-making approach.
- Excellent communication skills, including strong English language proficiency.
- Ability to assimilate new knowledge rapidly.
Work Environment and Additional Information
This is a full-time position based in Riyadh, Saudi Arabia. The role requires 5-10 years of experience. Biogen is committed to fostering a culture of inclusion and belonging, reflecting the communities where it operates and the patients it serves. The company believes that diverse backgrounds, cultures, and perspectives contribute to a stronger and more innovative company, focusing on building teams where every employee feels empowered and inspired. Biogen offers opportunities for learning, growth, and skill expansion, working collaboratively to deliver life-changing medicines.
