Associate Medical Director, Clinical Development Rare Movement Disorders

Biogen; Cambridge (MA); In loco; USD 194.000 - 267.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid vacation

Holiday time off

Sick time

Maternity/Parental leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Professional groups

Descrizione del lavoro

Biogen’s Rare Neurology Development Unit (RNDU) in Cambridge, MA, seeks an Associate Medical Director to advance early and late-stage programs for SMA, ALS and rare movement disorders. You will help design trials, interpret results, and guide regulatory interactions across global studies.

You will lead cross-functional teams, contribute to submissions, and support publications while staying current on regulatory guidelines for the field.

Competenze

• MD/PhD/PharmD with 5+ years of clinical research experience.
• Experience analyzing and interpreting clinical trials.
• Knowledge of GCP, trial design, biostatistics, and regulatory requirements.
• Strong organizational and project management skills in a global matrix.
• Proven ability to interact with diverse internal and external stakeholders.

Mansioni

• Support development and oversight of study protocols and reports.
• Monitor safety and efficacy data for assigned trials.
• Represent development on cross-functional study teams to ensure quality.
• Contribute to regulatory submissions and publications.
• Prepare investigator and advisory board materials with project teams.
• Stay current on regulations and guidelines for the therapeutic area.

Conoscenze

GCP knowledge

Trial design

Regulatory requirements

Biostatistics

Cross-functional collaboration

Project management

Communication skills

Formazione

MD/PhD/PharmD

5+ years clinical research experience

Descrizione del lavoro

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).

#LI-TD1

Job Level: Management

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