Job Description
About This Role
The position of Associate Medical Director, Clinical Development sits in the Immunology Therapeutic Area - a component of the Clinical Development Organization. The new Associate Medical Director will support one or more development programs involving products in lupus or other autoimmune disease. He/she works in close collaboration with the Medical Director and cross-functional clinical study teams to provide medical and scientific support for assigned programs in immunology. The initial focus will be in supporting the conduct of clinical trials in late stage development.
What You'll Do
- Will report to a senior member of the immunology clinical team who has direct responsibility for the overall research strategy and clinical and scientific development activities.
- Will support the conduct of clinical trials in conjunction with multiple functions, including data readout and analysis
- Monitor, review and interpret safety and efficacy data of ongoing studies;
- Act as (clinical medical/science expert) liaison to clinical study teams, CRO's, study sites and others;
- Participate in cross-functional clinical study team meetings;
- Drive development of protocols and study related documents for clinical studies;
- Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);
- Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice
- May interface with key medical experts and represent the team at medical congresses and conferences
Who You Are
You are passionate about bringing new treatments to your patients to change their life. You love learning new technological skills and working through collaboration.
Qualifications
Required Skills
The ideal candidate will have the following mix of professional and personal characteristics:
- MD/MD-PhD
- Rheumatology/Dermatology training
- One (1) to two (2) years of experience in clinical research in academia and/or industry.
- Capacity and willingness to work effectively in cross-functional team.
- Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
- Demonstrated critical thinking and detail oriented.
- 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.
- Proficiency in excel, word and powerpoint
Additional Information
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 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.
