Biogen is seeking a Medical Director for Clinical Development in Immunology to join our team in Cambridge, Massachusetts. In this pivotal role, you will be an essential member of the Immunology Therapeutic Area within our Clinical Development Organization. You will lead the design and execution of clinical programs focused on lupus and other autoimmune diseases, directly impacting the development of innovative treatments. Reporting to the Executive Director, you will be responsible for formulating clinical development strategies and overseeing complex clinical trials. Your leadership will bridge research and clinical operations, ensuring that patient needs guide our initiatives. This position offers an opportunity to contribute meaningfully to Biogen’s mission of advancing healthcare solutions while upholding the highest standards of efficacy and safety in our treatments. Your expertise will be vital in shaping the future of immunology therapeutics at Biogen.
| At-a-Glance | |
|---|---|
| Location | Cambridge, Massachusetts (US) |
| Salary | TBD |
| Closing Date | 1 Sep 2025 |
| Discipline | Biomedicine , Life Science |
| Job Type | Director |
| Duration | Permanent |
| Hours | Full time |
| Sector | Industry |
| Qualification | MD |
| Website | Visit |
Biogen, a leading biotechnology company, is seeking a Medical Director for Clinical Development in Immunology, based in Cambridge, Massachusetts. This pivotal role is situated within the Immunology Therapeutic Area of the Clinical Development Organization, where the successful candidate will play a crucial part in advancing clinical programs focusing on lupus and other autoimmune diseases. Reporting to the Executive Director, the Medical Director will be responsible for crafting and executing comprehensive clinical development strategies, thereby influencing the direction of clinical trials that align with Biogen’s commitment to innovation and patient care.
In this role, the Medical Director will oversee various clinical development activities, collaborating closely with the Research Unit to facilitate the transition of projects into Phase I and Proof of Concept (PoC) clinical activities. Key responsibilities include reviewing and contributing to essential clinical study documents such as Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), and regulatory submissions like Investigational New Drug applications (INDs). The Medical Director will also monitor and analyze safety and efficacy data from ongoing trials, ensuring that patient safety and treatment efficacy remain paramount.
Moreover, the Medical Director will serve as a clinical science expert, providing guidance to clinical study teams, Contract Research Organizations (CROs), and study sites. Engaging in cross-functional meetings, the individual will contribute valuable insights and foster relationships with both internal and external stakeholders. This role also encompasses supporting business development initiatives by offering clinical scientific expertise during due diligence processes.
Overall, the Medical Director, Clinical Development, Immunology at Biogen represents an opportunity to significantly impact the landscape of autoimmune disease treatment, aligning with the company’s mission to transform patient care through innovative therapies. The ideal candidate will possess a deep understanding of clinical development, a commitment to patient-centered outcomes, and a collaborative spirit that drives success in complex clinical environments.
Responsibilities
- Lead clinical development strategies for immunology-related therapies and programs.
- Oversee design and execution of clinical trials in immunology.
- Collaborate with cross-functional teams to ensure alignment on project goals.
- Monitor regulatory compliance and ensure adherence to clinical guidelines.
- Provide strategic insights to support product development and lifecycle management.
- Mentor and develop clinical development staff within the immunology division.
Qualifications
- MD or equivalent degree with specialization in immunology or related field.
- Extensive experience in clinical development and trial management.
- Proven leadership skills in cross-functional team environments.
- Strong understanding of regulatory requirements and compliance in clinical trials.
- Excellent communication and presentation skills for diverse audiences.
- Track record of successful immunology product development and commercialization.
Benefits
- Leads innovative clinical trials, advancing immunology treatments and improving patient outcomes.
- Collaborates with cross-functional teams, enhancing research efficiency and fostering a culture of excellence.
- Influences strategic direction, shaping the future of immunology therapies and company growth.
- Mentors emerging leaders, promoting professional development and strengthening the clinical development team.
