Associate Director, Clinical Trial Lead

About the role

Make a meaningful impact in this rewarding role with Biogen, a well-established pioneer in the pharmaceutical industry. This is your opportunity to transcend day-to-day management operations by designing operational strategy and overseeing clinical research organization (CRO) partners to develop clear protocol concepts and final protocols. You will own responsibility for entire clinical trial studies, including operational design, successful delivery, and positively impacting the lives of patients with neurological conditions such as 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 to make your vision a reality.

Responsibilities

• 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 fostering 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.

Requirements

• Bachelor’s 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 skills.
• 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.

Preferred Qualifications

• 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.

Benefits

• Medical, Dental, Vision, & Life insurances.
• Fitness & Wellness programs including a fitness reimbursement.
• Short- and Long-Term Disability insurance.
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31).
• Up to 12 company paid holidays + 3 paid days off for Personal Significance.
• 80 hours of sick time per calendar year.
• Paid Maternity and Parental Leave benefit.
• 401(k) program participation with company matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Employee Resource Groups participation.

Pay

The base compensation range for this role is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize future potential based on individual, business unit, and company performance.

About Biogen

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.