Associate Director, Clinical Trial Lead

Job Title: Associate Director, Clinical Trial Lead

Job Location: Remote, USA

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:

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.
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 experience

Job Level: Management Additional Information
The base compensation range for this role is: $162,000.00-$223,000.00
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 indiv