Our client is a public, mid-size (~350x heads) biotech using their proprietary gene therapy platform to develop potentially transformative treatments for serious diseases.The company has forged strategic partnerships with major biopharma companies including a development partnership for therapies with blockbuster potential with a Top Ten Global Big Pharma, and licensing agreements with companies leveraging our client's technology for treatments targeting rare genetic conditions.With an upcoming BLA submission, they're looking to add a physician to the team to lead their internal CNS program, as well as take on another CNS development program in the future.The opportunity: As Senior Medical Director, you will lead the development of a transformational gene therapy. You will play a key role in shepherding the candidate drug from pre-clinical stages through launch and lifecycle management. Responsibilites: Responsible for shaping clinical strategy, including development planning and cross-functional execution. Ensures alignment with corporate objectives while balancing time, resources, and risk.Collaborates with internal teams and external experts to design innovative clinical plans. Serves as the clinical lead on core program teams, providing strategic input and overseeing timelines.Leads clinical contributions to the Product Development Plan and ensures high-quality clinical sections. Presents development strategies and recommendations to senior leadership and key stakeholders.Chairs the Internal Safety Committee, overseeing safety monitoring across clinical studies. Manages medical monitoring activities and engages in advisory panels and investigator meetings.Reviews and contributes to clinical protocols, study reports, and publications, supporting a data-driven publication strategy. Engages with academic investigators to present and publish findings in scientific forums.Maintains expertise in regulations, guidelines, and therapeutic areas, ensuring best practices. Represents the company in the medical and scientific community to foster collaboration and thought leadership.Develops strong data analysis skills to interpret efficacy and safety outcomes, shaping key messages in alignment with product strategy and clinical practice.Qualifications: MDProven track record of experience and leadership in clinical trials/drug developmentPractical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodiesExperience with gene or cell therapies and/or rare orphan diseases preferredAbility to manage multiple and diverse internal/external collaborations at different stages of developmentExcellent listening and collaboration skill

Medical Safety Director Hybrid - Cambridge, MA Competitive Compensation Package Based on Experience$270,000 - $300,000 + Annual Bonus + Stocks SciPro Global is exclusively partnered with a Stable & steadily growing biotech that is doing incredible work with a pipeline across the Immunology and Oncology space. As their pipeline progresses, there are positions opening up in their Safety group. This group is solution oriented and full of team players, while being led by a direct, passionate, and impressive leader in the US. This position will report directly into the Senior Director Pharmacovigilance & Safety and provides unlimited career growth & stability with the technology that they are working on. Responsibilities include (but not limited to):Safety analysis of both clinical trials & post marketed products.Leading clinical safety aggregate reports such as PADERS.Leading risk mitigation and risk minimization measures for global studies, specifically working with RMPs.Responding to health authority queries regarding safety & risk sections of regulatory documents.Perform signal management & lead signal strategy measures.Safety surveillance of all assigned products.Cross functionally act as Safety SME for assigned products & liaise with other Clinical counterparts across the organization.Communicate safety updates with external & internal stakeholders.Provide safety input for clinical study design activities.Identify ways of improvement for team & safety group. Requirements include (but not limited to):Medical Director or Foreign Equivalent.Minimum 4 years of Safety experience working at a biotech or pharma.Strong signal detection experience required.Experience as safety lead for investigator brochures.Phase 1 Safety review experience.Solution Oriented mindset & motivated! Are you looking to join an exciting company to grow your career? Apply now to begin the process!

Vice President of Safety REMOTE Competitive Compensation Package Based on Experience One of SciPro Global's standing partners is looking to make their first Safety hire as their pipeline progresses. Our partner is an exciting Clinical stage Immuno-Oncology biotech located in the Massachusetts area. With impressive Clinical progress across different indications and growth over the last year or so, it's now time to make the key hire of a Head of Safety. This individual will be responsible for leading Strategy for safety, pharmacovigilance, and risk, build and manage the team, and collaborate cross functionally. As safety has been outsourced to this point, you will have the opportunity to bring it in house and develop the department accordingly. Reporting directly into the the SVP of Clinical Development, this role will be integral in the organization. Responsibilities include (but not limited to):Provide Safety expertise for all programs in pipeline both in the IO and ADC space.Managing existing PV team member & building the rest of the team.Strategically drive Safety forward while ensuring regulatory compliance.Lead, author and review clinical safety aggregate reports.Leading risk mitigation and risk minimization measures.Responding to health authority queries regarding safety & risk sections of regulatory documents.Perform signal management & lead signal strategy measures.Collaborate cross functionally with clinical development, regulatory, and quality assurance teams.Communicate safety updates with external & internal stakeholders. Requirements include (but not limited to):Medical Doctor or Foreign Equivalent.Minimum 15 years of Pharmacovigilance & Safety experience at a Biotech or Pharma.Experience leading a product through submission.Oncology experience preferred. Are you looking to join an cutting edge company to help the future of Oncology? Apply now to begin the process!

Duties & Responsibilities:Clinical Trial Compliance: Ensure project team remains compliant with national and international regulatory standards and guidance for medical devices.Audit Management: Develop and prioritize audit management plans and strategies for ongoing clinical trials and GCP programs. Plan, coordinate, and conduct internal system audits and external site/vendor audits in accordance with GCP guidelines.SOP Development: Participate in or lead the development of departmental standard operating procedures, work instructions, forms, and templates.Audit Reporting: Report audit findings to management, recommend resolutions, and verify corrective actions.Training: Conduct training for staff on GCP and inspection readiness.Regulatory Inspection Support: Prepare for and host regulatory inspections.Vendor Audits: Conduct initial and ongoing audits of clinical vendors such as CROs, imaging core labs, and central laboratories.Issue Escalation: Identify and escalate site, vendor, and study-related issues to management.Team Management: Recruit, train, and mentor Clinical Quality resources. Must haves:Bachelor's degree in scientific field of study10+ years supporting clinical research2+ years managing clinical trials5+ years in quality function2+ years of people managementMedical Device Industry experienceHosted Regulatory bodiesTravel domestically and internationally

Senior Regulatory Affairs Manager (m/w/d) - MedizintechnikIhre Aufgaben:Regulatorische Strategie und Planung: Entwicklung und Umsetzung von regulatorischen Strategien, Durchführung von Impact Assessments und Bereitstellung von strategischer Beratung.Technische Dokumentation: Erstellung und Pflege der technischen Dokumentation in enger Zusammenarbeit mit den Bereichen Forschung & Entwicklung, Qualitätssicherung und Klinische Abteilung.Globale Zulassungen: Vorbereitung und Verwaltung von Zulassungsdossiers, Koordination von Anmeldungen und Überwachung regulatorischer Neuerungen.Regulatorische Kommunikation: Hauptansprechpartner für regulatorische Gespräche und Kommunikation mit den zuständigen Behörden.Projektmanagement: Verantwortung für regulatorische Lieferergebnisse, Koordination von Teams und Sicherstellung der Einhaltung von Projektplänen.Post-Market Surveillance (PMS): Entwicklung und Pflege von PMS-Systemen, Gestaltung und Umsetzung von PMS-Plänen sowie Überwachung regulatorischer Dokumente.Berichterstattung von unerwünschten Ereignissen: Durchführung und Management von Untersuchungen zu unerwünschten Ereignissen, Leitung der Ursachenanalyse und Dokumentation.Datenanalyse: Analyse von PMS-Daten, Zusammenarbeit bei Bewertungen und Sicherstellung der Übereinstimmung mit dem Qualitätsmanagementsystem (QMS).Globale Compliance: Überwachung globaler PMS-Anforderungen, Bereitstellung von fachlicher Anleitung und Unterstützung bei Audits und Zulassungen. Ihr Profil:Ausbildung: Bachelor-Abschluss in Life Sciences, Biomedizinischer Technik, Regulatory Affairs oder einem verwandten Bereich. Eine Zertifizierung in Regulatory Affairs oder Projektmanagement ist von Vorteil.Berufserfahrung: 7-10 Jahre Erfahrung im Bereich Regulatory Affairs für In-vitro-Diagnostika (IVD) oder Medizinprodukte, mit nachgewiesener Erfahrung in der Produktentwicklung und globalen Zulassungen. Erfolgreiche Historie in regulatorischen Zulassungen und der Kommunikation mit Behörden.Fachliche Fähigkeiten: Umfassendes Verständnis globaler regulatorischer Rahmenbedingungen, Projektmanagementfähigkeiten, starke analytische und problemlösende Fähigkeiten sowie ausgezeichnete Kommunikationsfähigkeiten. Erfahrung in der Arbeit mit PMS-Tools und fundiertes Wissen in Risikomanagementprinzipien.Wir bieten:Ein dynamisches, internationales ArbeitsumfeldEine verantwortungsvolle Position mit viel GestaltungsspielraumAttraktive Entwicklungsmöglichkeiten und die Chance, die Zukunft der Medizintechnik aktiv mitzugestaltenInteressiert? Klingt das nach einer spannenden Herausforderung für Sie? Wenn Sie Teil des Teams werden möchten und die Zukunft der Medizintechnik mitgestalten wollen, freue ich mich auf Ihre Bewerbung.E-Mail: M.Inderhees@sciproglobal.deTel: 089 26 20 09 25