Medical Director, Clinical Development, Immunology

Summary

Join Biogen as a Medical Director, Clinical Development, Immunology, and play a critical role in shaping and advancing clinical programs for lupus and autoimmune diseases. Reporting to the Executive Director, you will lead the execution of complex clinical trials and contribute to the broader organizational objectives. Your expertise will bridge research and clinical operations, ensuring patient needs are prioritized. This role involves crafting clinical development strategies, monitoring safety and efficacy data, and collaborating with internal and external stakeholders. You will contribute to clinical study documents, regulatory submissions, and business development initiatives. Your contributions will significantly impact Biogen's mission to transform patient care in immunology.

Requirements

• 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

Responsibilities

• 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

Benefits

• 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