Associate Director, Clinical Trial Lead

Biogen, Inc.; Northern (KY); Hybrid; USD 171,000 - 236,000; Full time

Benefits offered by this job

Medical Insurance

Bonus & Equity

401(k) plan

Paid time off

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director to leadClinical Trial operations from a remote/onsite hybrid setup, guiding CRO partners and study teams to deliver robust protocols and efficient execution.

The role requires 8+ years in clinical operations, deep GCP/ICH knowledge, and strong leadership to drive cross-functional study planning and risk mitigation across multiple phases.

Qualifications

• Bachelor's degree in a scientific discipline.
• 8+ years in clinical operations management overseeing outsourced trials.
• Strong project-management, risk assessment, and communication skills.
• Deep knowledge of clinical development across phases I–IV.
• Expertise in GCP, ICH guidelines, and regulatory requirements.
• Ability to establish operational plans and support CROs.
• Proven CRO management in a Global Clinical Operations model.

Responsibilities

• Develop and oversee the study-level operational strategy for clinical studies.
• Chair SMT to develop robust, feasible concepts and protocols.
• Oversee CRO-delivered studies ensuring quality on time and budget.
• Partner with CRO SMT lead to risk-mitigation and issue resolution.
• Establish efficient, open-team culture with clear goals.
• Ensure compliant processes and cross-study synergies.

Skills

Science degree

Clinical operations management

Project management

GCP/ICH knowledge

CRO management

Operational planning

Regulatory familiarity

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS/PhD)

Job description

## Associate Director, Clinical Trial LeadApply: Off Campus: Remote, USA: Full time: Posted Today: REQ24079Make 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.**What You’ll Do*** 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.**Who You Are**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.**Required Skills*** 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**Preferred Skills*** 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 experienceJob Level: Management**Additional Information**The base compensation range for this role is: $171,000.00-$236,000.00Base salary offered 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 your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families *physical, financial, emotional,* and *social well-being*; including, but not limited to:* 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 **Why 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. 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. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.