Associate Medical Director, Clinical Development Rare Movement Disorders

Biogen, Inc.; Cambridge (MA); On-site; USD 194,000 - 267,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation + shutdown time

401(k) with company match

Tuition reimbursement

Employee stock purchase plan

Job summary

Biogen's Rare Neurology Development Unit seeks an Associate Medical Director to guide early and late-stage clinical programs in SMA, ALS, and rare movement disorders. You will drive trial design, endpoints, biomarkers, and regulatory interactions, reporting to the FA Clinical Development Director, and collaborate across global cross-functional teams in a highly matrixed environment.

This role emphasizes scientific leadership, rigorous interpretation of trial data, and proactive contributions to

Qualifications

• MD, Ph.D., and/or PharmD with at least 5 years of clinical research experience.
• Experience in analyzing and interpreting clinical trials.
• Knowledge of GCP, clinical trial design and execution, biostatistics, and regulatory requirements.
• Strong organizational and project management skills in a global matrix environment.
• Proven ability to interact with Clinical Operations, Regulatory, Biostatistics, and clinical investigators.

Responsibilities

• Support the development and oversight of study protocols, amendments, reports and regulatory documents.
• Monitor, review, and interpret safety and efficacy data of assigned clinical trials.
• Represent clinical development on cross-functional study management teams to ensure study quality metrics.
• Contribute to regulatory submissions, publications and presentations.
• Assist in investigator and advisory board meeting preparation and execution with project teams.
• Stay up to date on regulations and guidelines for the therapeutic area.

Skills

Clinical research

GCP knowledge

Regulatory knowledge

Biostatistics

Stakeholder management

Education

MD/PhD/PharmD degree

Job description

About This Role

The Rare Neurology Development Unit (RNDU) at Biogen is accountable for developing ground-breaking therapies in Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS), and Rare Movement Disorders (RMD) e.g., Friedreich Ataxia (FA) or Huntington's disease. As a member of the RMD and FA team, the Associate Medical Director will support early and/or late-stage program(s). This role will ensure the successful execution of clinical trials, in line with the strategic plan and assist the team in achieving innovative clinical trial designs, endpoints, biomarkers and in regulatory interactions. In this role you will report to the Director, FA Clinical Development.

What You’ll Do

• Support the development and oversight of study protocols and amendments, clinical study reports, training documents, and other clinical and regulatory documents.
• Monitor, review, and interpret safety and efficacy data of assigned clinical trials.
• Represent clinical development on cross-functional study management teams to ensure successful design and execution of clinical studies and achievement of study quality metrics.
• Contribute to regulatory submissions and interactions, publications, and presentations.
• Contribute 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 therapeutic area.

Who You Are

You are a driven team member who can think globally about advancing therapeutics and work effectively with cross-functional partners across multiple studies within the rare neurology / FA space. You have a strong understanding of 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.

Required Qualifications

• MD, Ph.D., and/or PharmD and 5 years of clinical research experience (academia and/or industry).
• Experience in analyzing and interpreting clinical trials.
• Demonstrated knowledge in GCP, clinical trial design and execution, biostatistics, 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 global matrix environment.
• Demonstrated success in interacting and building relationships with various internal/external stakeholders, such as Clinical Operations, Regulatory, Biostatistics, and clinical investigators.

Preferred Qualifications

• Experience in neurology and/or rare diseases.
• Experience with biomarkers, wearables and digital health technologies.
• Experience evaluating novel therapeutic mechanisms or emerging scientific platforms.
• Strong written and verbal communication skills.
• Ability to travel to scientific meetings and clinical sites occasionally as needed (domestic and international).

Job Level: Management

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Additional Information

The base compensation range for this role is: $194,000.00-$267,000.00. 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 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.

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.