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 AreScientifically 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 experience
Job Level: Management
Additional InformationThe base compensation range for this role is: -
Base 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
