Associate Director, Clinical Trial Lead

Make the most meaningful impact of your career in this rewarding role with Biogen, a well-established pioneer in the pharmaceutical industry. This is your rare opportunity to transcend day-to-day management operations as you design operational strategy and oversee our clinical research organization (CRO) partners to develop clear protocol concepts and final protocols. The best part: You will own responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of neurological conditions, including nephrotic conditions, multiple sclerosis (MS), Alzheimer’s disease, and spinal muscular atrophy (SMA). Working from home, office, or both on a flexible, hybrid schedule, you’ll have the support of a team with well-established procedures in place to make your vision a reality.

Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.

• Develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
• Chair the Study Management Team (SMT) to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
• Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
• Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
• Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
• Ensure effective, consistent, efficient and compliant processes.
• Champion synergies among other studies, programs, and development units to enhance excellence in study planning and execution.

• Bachelors Degree in a scientific discipline
• 8 + years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CRO
• Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skill
• Extensive knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development
• Unquestioned expertise in Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines and regulatory requirements for clinical development
• Ability to establish operational plans and support the CRO in executing them
• Effective CRO management skills and ability to adapt to the Global Clinical Operations (GCO) outsourcing model

• Experience operationalizing nephrology clinical studies
• An advanced degree, such as a master’s or Ph. D in a related field
• Investigator site and/or monitoring experience

Job Level: Management

The base compensation range for this role is: -

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.