Senior Director, Safety Science

The Role:

The Senior Director Safety Science will serve as a senior individual contributor providing strategic safety science leadership across Generates clinical-stage portfolio. This role will help shape the future capabilities standards and operating model of the pharmacovigilance function while remaining an individual contributor without formal people management responsibilities.

This role is designed for a highly experienced safety leader who can operate with broad autonomy influence senior cross-functional stakeholders and drive an integrated proactive and scientifically rigorous approach to signal detection aggregate safety assessment benefit-risk evaluation and safety governance across development programs. The Senior Director will be a key safety partner to Clinical Development Regulatory Medical Biometrics Translational and external partners ensuring that safety considerations are embedded in development strategy regulatory interactions and cross-functional decision-making. Success in this role will come from deep expertise sound judgment enterprise thinking and the ability to lead through influence in a fast-growing environment.

Heres how you will contribute:

• Provide strategic leadership for safety science across assigned development programs with accountability for integrated safety surveillance signal detection signal assessment aggregate review and benefit-risk evaluation.
• Shape the safety strategy for products advancing from early- to late-phase clinical development ensuring alignment with program objectives regulatory expectations and long-term portfolio needs.
• Lead cross-functional safety governance including Safety Management Teams and other safety review forums ensuring robust decision-making clear documentation and effective escalation of key risks.
• Drive high-quality interpretation of safety data from multiple sources including individual case reports aggregate datasets clinical studies literature and external data sources.
• Provide senior oversight and scientific direction for individual case review processes Analysis of Similar Events signal tracking and escalation pathways partnering closely with internal stakeholders and external vendors.
• Oversee the preparation and strategic quality of core safety deliverables including DSURs and other aggregate reports Reference Safety Information safety sections of Investigator Brochures protocols informed consent forms clinical study reports regulatory responses and other key documents.
• Represent Safety Science on cross-functional program teams and in interactions with external partners and regulatory authorities ensuring safety perspectives are clearly articulated and incorporated into development plans.
• Partner with Clinical Development and Regulatory leaders to support health authority interactions inspection readiness activities and submission-related safety strategies including support for future NDA BLA or other major regulatory milestones.
• Build and continuously improve pharmacovigilance processes governance SOPs standards and tools to enable scalability inspection readiness and operational excellence.
• Act as a senior technical leader and trusted advisor within Safety and across the broader organization raising the bar for scientific rigor decision quality and cross-functional alignment.
• Lead oversight of CROs and safety service providers establishing clear expectations monitoring performance and ensuring delivery against quality compliance and timeline commitments.
• Evaluate and implement fit-for-purpose systems analytics and digital capabilities that strengthen signal detection reporting data visibility and organizational scalability.
• Influence portfolio- and function-level decisions by translating complex safety data into clear recommendations for senior leadership and cross-functional stakeholders.
• Identify emerging risks dependencies and resource needs across programs and proactively drive mitigation plans that protect patients studies timelines and company objectives.
• Serve as a recognized internal expert in clinical safety science and contribute externally as appropriate through regulatory engagement scientific exchange and thought leadership in the field.
• Mentor colleagues share expertise generously and help strengthen functional capability across the organization without formal people management responsibility.

The Ideal Candidate will have:

• MD DO or equivalent with formal training and experience in patient care and clinical decision-making.
• Minimum of 12 years of experience in drug safety/pharmacovigilance within clinical development including at least 6 years in safety science roles with strategic responsibility for clinical-stage assets.
• Demonstrated experience serving as the senior safety science lead for one or more clinical programs with accountability for signal detection aggregate review benefit-risk assessment and safety input into development strategy.
• Strong experience supporting products across multiple stages of development ideally including assets transitioning from early- to late-phase clinical development.
• Deep knowledge of global pharmacovigilance regulations ICH guidelines signal detection practices aggregate reporting requirements and benefit-risk assessment.
• Strong clinical judgment and a demonstrated ability to interpret synthesize and communicate complex safety and clinical data to both technical and non-technical audiences.
• Track record of influencing cross-functional and senior stakeholders on complex safety issues including the ability to drive alignment and decision-making without direct authority.
• Experience leading or chairing safety governance activities and representing Safety Science on program teams and other cross-functional forums.
• Experience with regulatory authority interactions inspection readiness and major submission support activities; direct experience supporting NDA BLA or MAA activities is strongly preferred.
• Experience overseeing CROs vendors and external partners with strong command of quality compliance deliverable oversight and issue escalation.
• Demonstrated ability to operate with broad autonomy prioritize across competing demands and bring strategic perspective in a fast-paced evolving biotech environment.
• Familiarity with safety databases and analytics platforms such as Argus Veeva Safety Spotfire or related tools.
• Working knowledge of MedDRA Standardized MedDRA Queries Analysis of Similar Events and other core pharmacovigilance methodologies.
• Experience in biologics translational safety or emerging therapeutic modalities is a plus.
• Recognized subject matter expertise in safety science with the credibility to mentor colleagues shape functional standards and represent the function internally and externally as appropriate.

Who will love this job

• Senior individual contributors who want to operate with broad scope high accountability and meaningful influence across a growing development portfolio.
• People who can move fluidly between enterprise strategy and execution bringing both judgment and action to ambiguous high-growth environments.
• Individuals who value accountability candid collaboration and continuous learning and who elevate others through expertise partnership and influence.
• Builders who are excited to shape strategy standards and long-term functional capability without formal people management.

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About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creationone grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation this approach aims to reduce the uncertainty time and cost associated with developing protein-based medicines.

Founded in 2018 we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need faster guided by our values and leadership behaviors.

Generate:Biomedicines iscommitted to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Companys internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.