Medical Director, Clinical Development, Immunology

Job Description

About This Role:
As a Medical Director, Clinical Development, Immunology, you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. In this dynamic role, you will play a critical part in shaping and advancing clinical programs, particularly in the lupus and autoimmune disease space. Reporting to the Executive Director, you will be instrumental in crafting the clinical development strategy and leading the execution of complex clinical trials. Your leadership will not only impact the direction of clinical studies but also contribute to the broader objectives of the organization. Your expertise will be pivotal in bridging research and clinical operations, ensuring that the needs of patients are at the forefront of innovation and that the treatments developed meet the highest standards of efficacy and safety. Joining our team means taking on a role where your contributions significantly affect our mission to transform patient care in the realm of Immunology.

What You’ll Do:

• Report directly to the Executive Director, Clinical Development Immunology, overseeing the clinical development activities within Immunology.
• Collaborate with the Research Unit to facilitate the progression of projects into Phase I and Proof of Concept (PoC) clinical activities.
• Contribute to and review clinical study documents such as Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs), Patient Information Sheets/Informed Consent Forms (PIS/ICFs), and Statistical Analysis Plans (SAPs), along with regulatory submissions like INDs and Briefing Books (BBs).
• Monitor, analyze, and interpret safety and efficacy data from ongoing clinical trials.
• Serve as a clinical science expert for clinical study teams, Contract Research Organizations (CROs), and study sites.
• Engage in cross-functional clinical study team meetings, providing valuable insights and direction.
• Develop and deliver impactful presentations to internal teams and external stakeholders.
• Foster relationships with key external and internal stakeholders and contribute to decision-making panels.
• Offer clinical scientific expertise to support business development initiatives, including due diligence processes.

Who You Are:
You are a visionary in the world of clinical development, driven by a passion for delivering transformative treatments to patients and healthcare systems. You possess a natural curiosity that compels you to ask probing questions and the courage to drive innovation. Quality and ethical standards are your compass; you're meticulous in your work, insisting on excellence. Data is your ally, guiding your decisions and helping to explore how technology can accelerate progress in research and development. You're a team player who thrives in collaborative environments, yet you're also capable of standing on your own with strong problem-solving skills and analytical acumen.

Qualifications

Required Skills:

• MD or equivalent medical degree, with a preference for specialization in rheumatology, dermatology, or immunology.
• A minimum of five (5) years of clinical research experience within an academic or industry setting, encompassing phases I through IV.
• At least three (3) years' experience in all facets of clinical trial execution in the pharmaceutical industry, including planning, execution, reporting, and publication.
• Demonstrated ability to forge scientific partnerships with key internal and external stakeholders.
• Comprehensive understanding of Good Clinical Practice (GCP), clinical trial methodology, statistics, and the regulatory and clinical development landscape.
• A distinguished history in the field of immunology, encompassing both clinical and basic research.
• Autonomy in working environments, complemented by the ability to collaborate across functions, and exceptional skills in problem-solving, conflict resolution, and analysis

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Additional Information

The base salary range for this position is $202,000.00-$278,000.00. 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 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.