Associate Medical Director, Global Safety Physician

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $194k - $266.8k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Manage global pharmacovigilance for investigational and/or marketed products • Review and analyze safety data • Contribute to clinical trial design • Identify and investigate safety signals • Manage the benefit-risk profile for assigned compounds and products • Represent Biogen Safety in internal and external meetings • Serve as Global Safety Officer for a specific product when appointed • Keep upper management informed of safety issues • Demonstrate flexibility across multiple disease areas • Advance the safety and biological understanding of compounds through their life cycle • Interact with management, external medical stakeholders, and global regulatory authorities • Manage safety surveillance for assigned products • Collaborate with PV scientists and other stakeholders • Analyze safety trial data • Ensure appropriate summarization and handling of adverse events, including seriousness, expectedness, and causality decisions • Provide safety strategic leadership for clinical development programs • Integrate safety science into strategic clinical development plans • Develop and maintain relationships with Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, and Worldwide Medical • Ensure accurate and timely completion and reporting of periodic and expedited safety reports in compliance with internal and regulatory timelines

🎯 Requirements

• MD required • Subspecialty focus in neuroscience, psychiatry, immunology, or rare diseases preferred • Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting • Ideally 1+ years of overall experience specific to pharmacovigilance • Prior experience in clinical trials, academic and/or industry • Knowledge of pre- and post-marketing US and EU regulations • Proven leadership experience • Experience working with or leading high-performing teams • Position based in Cambridge, MA (USA)

🏖️ 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 • 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 • Short term and long-term incentives, including cash bonus and equity incentive opportunities • Opportunities for learning, growth, and expanding skills