Associate Medical Director, Global Safety Physician

Biogen

13d•$184,000 - $253,000•Onsite

About The Position

The Global Safety Physician is responsible for global pharmacovigilance for investigational and/or marketed products. This includes reviewing and analyzing safety data, contributing to clinical trial design, identifying and investigating safety signals, and managing the benefit-risk profile of assigned compounds and products. The physician represents Biogen Safety in internal and external meetings and may be appointed Global Safety Officer for a specific product. The role also keeps upper management informed of safety issues. The position requires flexibility and the ability to work at a high level across multiple disease areas in an entrepreneurial environment, advancing the safety and biological understanding of compounds throughout their life cycle. The physician interacts with multiple levels of Biogen management, external medical-community stakeholders, and global regulatory authorities. The role is based in Cambridge, Massachusetts, USA. The base compensation range is $184,000–$253,000. Regular employees may also be eligible for short- and long-term incentives, including cash bonuses and equity incentives.

Requirements

MD required.
Minimum 3 years of experience in the pharmaceutical industry or a clinical care setting.
Prior experience in clinical trials, academic and/or industry.
Knowledge of pre- and post-marketing US and EU regulations.
Demonstrated leadership and experience working with or leading high-performing teams, including providing guidance and mentoring.

Nice To Haves

Subspecialty focus in neuroscience, psychiatry, immunology, or rare diseases preferred.
Ideally 1 or more years of overall experience specific to pharmacovigilance.

Responsibilities

Manage safety surveillance for assigned products.
Collaborate with pharmacovigilance scientists and other stakeholders.
Conduct analyses of safety trial data.
Ensure adequate summarizing and handling of adverse events for investigational and/or marketed Biogen products, including decisions about seriousness, expectedness, and causality.
Provide safety strategic leadership for clinical development programs.
Integrate the safety scientific component into a strategic framework for clinical development plans.
Develop and maintain relationships with counterparts in 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-authority timelines.
Represent Biogen Safety in internal and external meetings and keep upper management informed of safety issues.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short- and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.