Job Description
About This Role
Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
As a Clinical Trial Manager, you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share 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 immune-mediated diseases. This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis.

What You’ll Do

• Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
• Chair and Co-Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
• Provide operational guidance to sites, CRO and other key suppliers
• Provide operational oversight of clinical study suppliers
• Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
• Attend scientific meetings
• Strategize and coordinate efforts to ensure completeness of eTMF
• Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
• Manage budget, approve invoices and participate in the monthly accrual process
• Participate in the testing of clinical study systems including IRT and EDC
• 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.

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.
Qualifications

Required Skills & Experience

• Bachelor’s degree in a scientific discipline with 7 years of professional work experience in the life sciences
• 5 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 Experience

• Sponsor and/or CRO Global trial management experience
• Investigator site and/or monitoring experience

Additional Information
The base compensation range for this role is $119,000-160,000. Base salary offered is determined though 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 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

• Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
• Chair and Co-Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
• Provide operational guidance to sites, CRO and other key suppliers
• Provide operational oversight of clinical study suppliers
• Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
• Attend scientific meetings
• Strategize and coordinate efforts to ensure completeness of eTMF
• Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
• Manage budget, approve invoices and participate in the monthly accrual process
• Participate in the testing of clinical study systems including IRT and EDC
• 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