Medical Director, Drug Safety & Pharmacovigilance 2020686
Location: Cambridge MA (Onsite)
Science/ Focus: CRISPR/Cas9
Therapeutic Area: Rare Disease
Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
Primary Job Responsibilities:

• Collaborate with the clinical development team to develop and implement a comprehensive safety surveillance strategy for clinical trials across different platforms.
• Manage and prioritize safety signals by leading a cross-functional safety management team, ensuring effective risk mitigation and response.
• Lead a cross-functional project focusing on the development of guidance for the long-term safety assessment of gene-editing products, ensuring compliance with regulatory requirements and best practices.

• MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics
• Strong knowledge and hands-on experience with good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines.
• Proven track record of leading and authoring safety guidance documents, position papers, and safety sections of IND or BLA submission dossiers.
• Prior experience in gene therapy products or biologics, demonstrating the ability to navigate the unique challenges of pharmacovigilance in these areas.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.