Enliven Therapeutics, Inc.
Senior Director, Global Regulatory Affairs Lead
Enliven Therapeutics, Inc., Baltimore, Maryland, United States
Overview
All Jobs > Senior Director, Global Regulatory Affairs Lead Senior Director, Global Regulatory Affairs Lead Fully Remote • Remote • Regulatory Affairs Full-time About the Role
Position: Senior Director, Regulatory Affairs Lead Department: Regulatory, Quality, and Safety Location: On-Site or Remote USA Status: Full-time Exempt About Us
Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs Role Purpose
We are seeking a (Senior) Director of Regulatory Affairs who will be accountable for leading the development and implementation of the global regulatory strategy for several programs in our clinical pipeline spanning early and late development. The Director will serve as the Global Regulatory Lead for 1-2 investigational products and/or indications. The candidate will be responsible for ensuring that the strategy is designed to deliver timely approval and labeling consistent with the needs of patients, prescribers, payors, governments, and health authorities. The Director of Regulatory Affairs should possess strategic leadership skills, have a deep understanding of global regulatory science and overall small molecule development processes for complex or novel development programs. Experience and knowledge in oncology is desired to enable collaboration with cross-functional development and business leaders, health authorities, consultants, and other stakeholders. Responsibilities
Leads project teams in implementing and delivering the regulatory strategy across multiple early and/or late-stage programs Develop Regulatory Strategy for complex programs in oncology Participates in cross-functional teams as regulatory project lead, providing regulatory strategic guidance and support Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans Drives health authority interactions, including planning, briefing material development, and meeting preparation leadership Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises Development Teams accordingly. Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities Partners with external vendors in support of regulatory document preparation and submission Leads and executes non-project regulatory activities Demonstrates capability and credibility in complex, business critical projects as well as ability to cope with ambiguity and manage key stakeholders. Qualifications
MD/DO degree with 5+ years of drug development experience, with 3+ years acting as a safety medical monitor in industry Board certification in oncology is preferred Demonstrated expertise in medical evaluation and safety surveillance, ideally in nephrology or immunology therapeutic areas In-depth understanding of pharmacovigilance data, including clinical and post-marketing safety information, with the ability to interpret and act on complex findings. Well-versed in global drug safety regulatory frameworks, including ICH guidelines, 21 CFR, and EU GVP requirements for investigational products Hands-on experience with safety data analysis, MedDRA coding, and adherence to international PV standards and practices. Highly organized and adaptable, with strong written and verbal communication skills, and the ability to operate effectively in a fast-paced, evolving environment. Proven ability to manage cross-functional collaborations, lead discussions on safety strategy, and resolve complex patient safety concerns. Skilled in translating safety data into clear, actionable insights and communicating effectively across internal teams, leadership, and regulatory authorities. A “can do” attitude and ability to operate in a fast-paced startup environment The expected salary range for this position is $270k - $330k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen. Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.
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All Jobs > Senior Director, Global Regulatory Affairs Lead Senior Director, Global Regulatory Affairs Lead Fully Remote • Remote • Regulatory Affairs Full-time About the Role
Position: Senior Director, Regulatory Affairs Lead Department: Regulatory, Quality, and Safety Location: On-Site or Remote USA Status: Full-time Exempt About Us
Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs Role Purpose
We are seeking a (Senior) Director of Regulatory Affairs who will be accountable for leading the development and implementation of the global regulatory strategy for several programs in our clinical pipeline spanning early and late development. The Director will serve as the Global Regulatory Lead for 1-2 investigational products and/or indications. The candidate will be responsible for ensuring that the strategy is designed to deliver timely approval and labeling consistent with the needs of patients, prescribers, payors, governments, and health authorities. The Director of Regulatory Affairs should possess strategic leadership skills, have a deep understanding of global regulatory science and overall small molecule development processes for complex or novel development programs. Experience and knowledge in oncology is desired to enable collaboration with cross-functional development and business leaders, health authorities, consultants, and other stakeholders. Responsibilities
Leads project teams in implementing and delivering the regulatory strategy across multiple early and/or late-stage programs Develop Regulatory Strategy for complex programs in oncology Participates in cross-functional teams as regulatory project lead, providing regulatory strategic guidance and support Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans Drives health authority interactions, including planning, briefing material development, and meeting preparation leadership Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises Development Teams accordingly. Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities Partners with external vendors in support of regulatory document preparation and submission Leads and executes non-project regulatory activities Demonstrates capability and credibility in complex, business critical projects as well as ability to cope with ambiguity and manage key stakeholders. Qualifications
MD/DO degree with 5+ years of drug development experience, with 3+ years acting as a safety medical monitor in industry Board certification in oncology is preferred Demonstrated expertise in medical evaluation and safety surveillance, ideally in nephrology or immunology therapeutic areas In-depth understanding of pharmacovigilance data, including clinical and post-marketing safety information, with the ability to interpret and act on complex findings. Well-versed in global drug safety regulatory frameworks, including ICH guidelines, 21 CFR, and EU GVP requirements for investigational products Hands-on experience with safety data analysis, MedDRA coding, and adherence to international PV standards and practices. Highly organized and adaptable, with strong written and verbal communication skills, and the ability to operate effectively in a fast-paced, evolving environment. Proven ability to manage cross-functional collaborations, lead discussions on safety strategy, and resolve complex patient safety concerns. Skilled in translating safety data into clear, actionable insights and communicating effectively across internal teams, leadership, and regulatory authorities. A “can do” attitude and ability to operate in a fast-paced startup environment The expected salary range for this position is $270k - $330k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen. Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.
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