Job Description
About This Role
The Neuromuscular Development Unit at Biogen is accountable for developing ground-breaking therapies in Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS), and muscle diseases from early to late-stage clinical development. As a member of the team, the associate medical director will work on late-stage SMA programs and potentially contribute to other programs and/or develop our platform capabilities. This role will drive the progression of a deep clinical portfolio and assist the team in achieving innovative clinical trial designs, biomarkers, clinical endpoints, and regulatory interactions.
What You'll Do
- Represent clinical development on several cross-functional Study Management teams to ensure successful design and implementation of clinical studies in Spinal Muscular Atrophy (SMA) and achievement of study quality metrics.
- Support the development and oversight of study protocols and amendments, clinical study reports, training documents, and other clinical and regulatory documents.
- Responsible for clinical trial design, execution, and interpretation of clinical trial results, contribution to regulatory submissions and interactions, publications, and presentations.
- Contributes to the preparation and execution of investigator and advisory board meetings in partnership with project teams and stakeholders.
- Remain up to date on regulations and guidelines for the supporting therapeutic area.
Who You Are
You are a driven team member who can think globally about advancing therapeutic units and work effectively across multiple studies within the SMA space. You understand clinical trial design, execution, and interpretation of clinical trial results and contribute to regulatory submissions and interactions. You are effective in a highly matrixed environment and possess expert knowledge of scientific medical and regulatory information for publications and presentations.
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Qualifications
Required Skills:
- MD, MD/Ph.D., Ph.D., or PharmD and at least 5 years of clinical research experience (academia or industry) is required.
- Experience in analyzing and interpreting clinical data (safety and efficacy), working knowledge of biostatistics, clinical trial design and execution, GCP, and regulatory requirements for clinical studies.
- High level of organizational and project management skills with the ability to work collaboratively in a fast-paced, team-based matrix environment. Excellent written and verbal communication skills.
- Demonstrated success in interacting and building relationships with various internal/external stakeholders, such as Clinical Operations, Regulatory, statistics, and clinical investigators.
- Ability to be flexible travel to scientific meetings and clinical sites as needed (domestic and international).
Additional Information
The base compensation range for this role is $161,000 to $267,000 base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
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 our DE&I efforts.
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.