Associate Medical Director, Rare Neurology Outcome Development
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What you'll do
- Support the development, qualification, and implementation of novel outcome measures, including biomarkers, digital endpoints, and clinical outcome assessments across the Rare Neurology portfolio.
- Contribute to the evaluation and refinement of existing outcome measures using internal and external datasets.
- Support the design and execution of outcome development studies, natural history studies, and methodology research initiatives.
- Collaborate with internal and external experts to advance patient-centered approaches to outcome measurement.
- Contribute to endpoint strategy discussions for clinical development programs and support interactions with regulatory authorities and external stakeholders.
- Support scientific communications, publications, congress presentations, and external collaborations related to outcome development.
- Partner with program teams and functional stakeholders to contribute to Integrated Evidence Plans and align evidence generation activities with key development objectives.
What they're looking for
- Ph.D., MD, and/or PharmD and 5 years of clinical research experience (academia and/or industry).
- Experience with Clinical Outcome Assessment strategy and implementation including outcome measure development, validation, and qualification and/or endpoint selection for clinical trials.
- Experience in analyzing and interpreting clinical trials.
- Demonstrated knowledge of 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.
Nice to have
- Experience in Epidemiology, Clinical Development, HEOR, or Evidence Generation.
- Experience in neurology and/or rare diseases.
- Experience contributing to pipeline portfolio strategy or therapeutic area strategy.
- Experience with biomarkers, wearables and digital health technologies.
- Strong written and verbal communication skills.
- Ability to travel to scientific meetings and clinical sites occasionally as needed (domestic and international).
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
About This Role
We are seeking a highly motivated Associate Medical Director, Rare Neurology Outcome Development to support the development and implementation of innovative outcome measures and integrated evidence generation strategies across our Rare Neurology portfolio. Working closely with the Rare Neurology Outcome Development Lead and cross-functional colleagues, this individual will contribute to the evaluation, refinement, and operationalization of biomarkers, digital endpoints, clinical outcome measures, and evidence generation approaches that support development in therapeutic areas in the Rare Neurology Development Unit.
There is an urgent need for objective, sensitive, and patient-relevant outcome measures to facilitate the development and optimization of therapies for people living with neuromuscular and other rare neurologic diseases. Leveraging data generated within our Rare Neurology programs and external datasets, the Associate Medical Director will contribute to efforts to assess existing measures, identify opportunities for novel endpoint development, and generate evidence supporting their use across the product development lifecycle. In addition to outcome development activities, this individual will support the evolution and implementation of an integrated evidence generation framework for early-stage assets.
What You’ll Do
Support the development, qualification, and implementation of novel outcome measures, including biomarkers, digital endpoints, and clinical outcome assessments across the Rare Neurology portfolio.
Contribute to the evaluation and refinement of existing outcome measures using internal and external datasets.
Support the design and execution of outcome development studies, natural history studies, and methodology research initiatives.
Collaborate with internal and external experts to advance patient-centered approaches to outcome measurement.
Contribute to endpoint strategy discussions for clinical development programs and support interactions with regulatory authorities and external stakeholders.
Support scientific communications, publications, congress presentations, and external collaborations related to outcome development.
Partner with program teams and functional stakeholders to contribute to Integrated Evidence Plans and align evidence generation activities with key development objectives.
Who You Are
You are a driven team member who can think globally about advancing endpoint development and work effectively with cross-functional partners across multiple studies within the rare neurology space. You have a strong understanding of outcome development, evidence generation, clinical trial design, and interpretation of clinical trial results.
Required Qualifications
Ph.D., MD, and/or PharmD and 5 years of clinical research experience (academia and/or industry).
Experience with Clinical Outcome Assessment strategy and implementation including outcome measure development, validation, and qualification and/or endpoint selection for clinical trials.
Experience in analyzing and interpreting clinical trials.
Demonstrated knowledge of 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 Epidemiology, Clinical Development, HEOR, or Evidence Generation.
Experience in neurology and/or rare diseases.
Experience contributing to pipeline portfolio strategy or therapeutic area strategy.
Experience with biomarkers, wearables and digital health technologies.
Strong written and verbal communication skills.
Ability to travel to scientific meetings and clinical sites occasionally as needed (domestic and international).
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Additional Information
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.
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