Senior Medical Director Global SafetyCompetitive Compensation Package Based on Experience$320,000 - $375,000 + 25% Bonus + RSU'sSciPro Global is partnered with an exciting company working in the cell therapy space, with a product on the market already, looking to make a key Safety hire. This is a Senior Medical Director Safety position being the SME within the company in Safety. As this position right now sits in the Clinical Development group, you will have the potential to grow into the Head of Safety in the future. With multiple studies across cell therapy and incoming studies in the metabolic space, it's an exciting time to join this company and grow into a leadership position. Responsibilities include (but not limited to): Safety analysis of both clinical trials & post marketed products.Being Safety Strategy SME and communicating safety strategy across functions.Leading clinical safety aggregate reports.Leading risk mitigation and risk minimization measures for global studies, specifically working with RMPs.Organize and lead SMT meetings.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.Oversight of CRO.Manage and lead safety scientist and operations team members.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.  Requirements include (but not limited to): Medical Director or Foreign Equivalent.Cell therapy or Myeloma experience required.Minimum 5 years of Safety experience at a pharmaceutical company or biotech.Submission experience with IND and BLA/NDA.Experience leading Safety meetings and managing a team.  Are you looking to finally have that leadership experience and be the Safety SME? Apply now to begin the process!

SciPro is currently partnered with a well-funded oncology focused biotech to hire a Senior Medical Director for their clinical development team. This role would be focused on early phase clinical trials across several indications.Key Responsibilities: Design and execution of clinical development plansResponsible for medical monitoring of key studiesProvide medical input for protocols, IBs, CSRs, regulatory responses and submissionsInterface with other key leaders and team members within the company Qualifications: MD or MD/PhDIndustry clinical development experience Previous oncology experienceExperience in early clinical development preferredAbility to interface with and provide oversight over the cross-functional clinical team

Company OverviewA clinical-stage biotechnology company recently established through a reverse merger and restructuring, with a current headcount of fewer than 20 employees. The company is focused on developing therapies for autoimmune and chronic inflammatory diseases.The pipeline is anchored by a next-generation, best-in-class potential BTK inhibitor, advancing toward Phase II trials in (planned initiation in early 2026). The company is supported by prior fundraising and is currently conducting a new financing round with strong investor connections.Core functions are already in place across bioanalysis, translational research, nonclinical development, and CMC. Role Overview The company is seeking an experienced clinical development leader to provide hands-on operational and scientific leadership as the BTK inhibitor program advances into Phase II. This position is designed to bridge a current leadership gap, as existing senior executives are focused on strategic rather than day-to-day execution.Responsibilities  Depending on experience, leads or represents the clinical function in multifunctional project and study teams.Stays abreast of internal and external developments, trends and other dynamics relevant to the work of Clinical Development to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the pipeline.Maintains the highest standards and levels of scientific and clinical knowledge in chronic inflammatory and autoimmune disease.Acts as the primary sponsor medical monitor for assigned studies and works with external vendors and internal functions to ensure the highest standard of data quality and medical oversight.Accountable for CDP execution: objectives and deliverables are consistently accomplished in a timely, on-target and high-quality manner within budget guidance.Designs clinical studies and develops protocols in alignment with the strategies set by the Portfolio Management Committee.Supports clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions regarding assigned studies.Acts as clinical lead in the development of study analytics, medical monitoring plans, safety management plans and data management plans.Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicates any issues, challenges and potential strategies for resolution.Collaborates with drug safety representatives and others in the development of the product safety profile.Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.Supports others with clinical science information and input for regulatory submissions and other regulatory processes.Drives ongoing data generation, review, and communication to inform or enhance the design or interpretation of ECD studies or other programs and recommend new or modified ECD studies in the assigned therapeutic area.Completes and/or leads other special projects as assigned. Qualifications & Experience  M.D/PhD with relevant medical and research experience in autoimmune and chronic inflammatory disease particularly in Dermatology, Rheumatology, Neurology or Gastroenterology.At least 5 years pharma/biotech industry experience in clinical development OR is a recognized clinician-scientist expert in the field with equivalent clinical.Comprehensive understanding of product and safety profiles.Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.Preferred: Experience submitting an IND to regulatory authorities in Europe and/or the U.S.Preferred: Experience authoring aspects of a global clinical development plan or full clinical study protocol.Preferred: Experience publishing results of clinical drug trials in a refereed journal.

Medical Director - Safety Physician Remote SciPro Global is exclusively partnered with a Stable & quickly growing company that is doing incredible work with a pipeline across Therapeutic Areas from Oncology to Cardiovascular to Immunology to CNS to Respiratory. As they expand their pipeline, there are over 30 programs in Phase 1 & 2 right now which has led to massive growth in their Safety group. This team 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 Oncology Therapeutic Area Safety Head 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 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 7 years of Pharmacovigilance & Safety experience at a Biotech or Pharma. Management experience. Solution Oriented mindset & motivated!   Are you looking to join a brand name company to grow your career?   Apply now to begin the process!

Senior Regulatory Manager CMC (m/w/d) || Pharma || Standort: NorddeutschlandVertragsart: Vollzeit In dieser Rolle übernehmen Sie die regulatorische Verantwortung für internationale Projekte mit Schwerpunkt auf den Märkten der EU und der USA. Dabei sind Sie die zentrale Schnittstelle zwischen internen Abteilungen und externen Partnern wie Behörden, Kunden und Dienstleistern. Das sind Ihre Aufgaben: Betreuung und Steuerung von Zulassungsprojekten in allen Phasen – von der Erstellung der Zulassungsunterlagen (CMC) bis zur Bearbeitung von Rückfragen Entwicklung und Umsetzung von Zulassungsstrategien unter Berücksichtigung von Daten, Marktexklusivität und regulatorischen Anforderungen Erstellung und Prüfung von Dossiers (Module 2–5) sowie Koordination externer Partner Bearbeitung von Fragestellungen zur pharmazeutischen Qualität in enger Zusammenarbeit mit der klinischen Entwicklung Bewertung regulatorischer Dokumente im Rahmen von Lizenzprojekten und Due-Diligence-Prüfungen Sicherstellung der Einhaltung aktueller nationaler und internationaler Richtlinien Unterstützung bei behördlichen Verfahren (z. B. Scientific Advice, Controlled Correspondence) Ihr Profil: Abgeschlossenes naturwissenschaftliches Studium (z. B. Pharmazie, Chemie, Biologie) Mehrjährige Erfahrung (mindestens 5 Jahre) im Bereich Regulatory Affairs. Nachweisliche Begleitung von Generika-Zulassungen Erfahrung in der Erstellung und Submission von Dossiers (FDA & EU). Erfahrung mit Hybridanträgen. Stark in Zulassungsstrategie und Behördenkommunikation (FDA, EMA, Scientific Advice). Erfahrung in der Zusammenarbeit mit externen Partnern. Mentoring- oder Coaching-Kompetenz, um Teammitglieder zu entwickeln. Das bietet Ihnen das Unternehmen: Spannende internationale Projekte mit hoher Eigenverantwortung Gestaltungsfreiraum in einem dynamischen Umfeld Kurze Entscheidungswege und ein kollegiales Team Möglichkeiten zur fachlichen und persönlichen Weiterentwicklung Spricht Sie diese Position an? Dann sollten Sie sich gleich bewerben! Falls Sie gerne weitere oder alternative Positionen erhalten möchten, würde ich mich ebenfalls über Ihre Bewerbung freuen! Bewerbungsprozess: Lebenslauf an meine E-Mail: m.inderhees@sciproglobal.de Telefonat mit Vorstellung des Unternehmens Ich bin Ihr Ansprechpartner für den sämtlichen Bewerbungsprozesses (Interviews bis Vertragsverhandlungen) d.h. Sie müssen sich nicht selbst bewerben Besprechen weiterer exklusiver Stellen, welche Ihrem Profil zugeschnitten sind Meine Kontaktdaten im Überblick: E-Mail: m.inderhees@sciproglobal.de Tel: 0049 (0) 89/ 26 20 09 25 (Durchwahl)