Job Description
About This Role:
We are seeking a highly motivated Senior Medical Director to lead development strategy and oversee the clinical development team for one or more assets in the areas of neuropsychiatry and pain in programs that span from first in human studies through filings and approval as well as post-marketing commitments and label-expansion studies.
The position of Senior Medical Director, Clinical Development is a leadership member of the Therapeutics Development Unit reporting to the Development Unit Head and leads a group of medical directors and clinical scientists and provides medical/clinical expertise covering the articulation of the clinical development plan, including regulatory strategy, scientific analysis etc., and strategy in the therapeutic areas. The role will liaise with business development needs / external innovation activities.
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The position holder will also provide input and execution of initiatives at the Development Unit level and for broader Development and Medical function and Biogen activities. The lead will interact with functions across the company and in particular other development and medical functions, research, commercial, and value and access. The lead may represent clinical development on collaboration committees with external parties and be a core member of Product Development and Commercialization teams as well as Research and Development Program Teams and interact with external stakeholders in the medical and scientific community and global regulatory authorities.
Reporting to the Head of the Therapeutics Development Unit, this team oversees therapeutic areas of Neuropsychiatry, Pain, and rare Epilepsies and Genetic and Neurodevelopmental disorders, this role will contribute to our mission to create first in class and/or best in class therapies for disorders with significant unmet needs utilizing the modality best suited for the therapeutic opportunity ( e.g., small or large molecule, biologic, ASO, or gene therapy) This role may serve as a delegate for the TDU Head at Development Leadership Meetings and other strategic or governance forums.
What You’ll Do :
- Provide strategic leadership and medical expertise within the Clinical Development neuropsychiatry and CNS space and deliver on developing, executing and advancing strategic and successful development programs for yourself and while providing mentorship and over to team members for their programs.
- Demonstrate leadership and team-building skills as well as the ability to perform effectively in a multi-disciplinary environment
- Demonstrate excellent communication skills (oral and written) and excellent organizational skills
- Show the capacity and willingness to work effectively across disease areas as needed
Support the Head of Development Therapeutics for all affairs related to your therapeutic areas
Represent your team and portfolio in relevant governance and strategic forums
Integrate scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, product development plan, and commercial goals to build a solid strategic framework for each clinical development plan (CDP).
Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP
Represent team and medical viewpoint externally, as appropriate, with Regulators, Policymakers and value assessments
Develop and maintain relationships with R&D Project Leaders and program counterparts in Commercial, Research, Regulatory, Biomarkers, Clinical Operations and Statistics, Value & Access, Worldwide Medical
Establish and drive external collaborations, forge relationships with key opinion leaders/medical experts and partners
Contribute to specified Business Development activities.
Present and publish high-level clinical data in international meetings and journals
Who You Are:
You are a scientific or clinical professional with a passion for science and deep scientific knowledge with proven ability to deliver and drive clinical development across the entire development spectrum and collaborate with research colleagues on therapeutic strategy and to ready relevant assets for transition from research into development. You are an experienced manager who values diversity, equity, and inclusion and who values bringing the best out of others and enabling them to achieve their full potential. You are a strong leader with a strategic & innovative style, able to adjust your style to the needs of the person or situation, bringing innovation and flexibility with a high sense of urgency. You have a marked curiosity about science, medicine, healthcare and business opportunities. You keep patients, payers and physicians top of mind in your daily work and collaborate to solve critical scientific and business challenges.
Qualifications
Required Skills:
MD, PhD (life sciences), or PharmD (or combinations) required
At least six (6) years of experience in clinical research. Industry experience in clinical development essential; neuropsychiatry experience peferred; pain experience preferred but not required
Extensive knowledge of basic and clinical science, and R&D. A broad understanding of neuropsychiatry and neurologic disease areas a significant plus, established links with the medical community around the world
Demonstrated dynamic leadership and team-building skills as well as the ability to perform effectively in an adaptive environment
Demonstrated strategic and critical thinking
Excellent communication skills (oral and written) and excellent organizational skills
The ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
*This is a Hybrid role based out of Cambridge, MA
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Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.