Medical Director, Clinical Development, Immunology

Biogen•Cambridge, MA

10d

About The Position

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.

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

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