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Clinical scientific program lead (all genders)

Wedel
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Inserat online seit: 18 Juni
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Clinical Scientific Program Lead (all genders)
Wedelnear HamburgAbout medacWe are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry. Look into this job opportunity and become part of an exceptional workforce.At our location innear Hamburg, we are looking for aclinical scientific program lead (all genders).About the RoleClinical science program lead with extensive expe rience in global clinical develop ment across Phase I–IV, with a strong focus on auto immune diseases, immunology, and inno vative therapiesProven track record in designing smart, integrated clinical development programs, evaluating new assets through due diligence, and advancing lifecycle strategies, including indication extensions and territory expansionsExperienced in leading cross-functional teams, delivering high-quality data packages, and driving successful interacctions with regulatory authorities (EMA / FDA)Recognized for strategic thinking, scientific rigor, and impactful stakeholder engagementYour tasksLead global clinical development programs across Phase I–III trials, overseeing multiple studies and ensuring high-quality execution, data integrity, and timely deliveryDesign and drive efficient, integrated clinical development strategies, including Clinical Development Plans (CDPs) and Target Product Profiles (TPPs), aligned with scientific, regulatory, and commercial objectivesProvide strategic leadership in autoimmune and immunology indications, including lifecycle management, indication extensions, and territory expansion initiativesConduct due diligence and evaluation of new assets, supporting in-licensing decisions through scientific and clinical risk-benefit assessmentsServe as the key medical and scientific interface with regulatory authorities (EMA / FDA), leading scientific advice interactions and supporting submission strategiesOversee development and quality of core clinical and regulatory documents, ensuring consistency and scientific rigor across all deliverablesYour profileMedical doctor (MD), pharmacist, or equivalent life sciences degree with ideally five years of international clinical research experience (Phase I–III)Strong expertise in autoimmune diseases, rheumatology, immunology, and pharmacologyProven experience in clinical development strategy, including design of efficient development programs, CDPs, and study protocols, as well as support of indication and territory expansionsSolid background in asset evaluation and due diligence, including scientific and clinical assessment of new compoundsExperience with regulatory interactions and submissions (EMA and / or FDA), with strong knowledge of GCP/ICH and applicable regulationsDemonstrated leadership, strategic thinking, and cross-functional collaboration skills, combined with strong analytical and communication capabilitiesFluency in English; German is an assetOur offerOur employees are our greatest asset. And to show our appreciation, we offer attractive benefits:Your work-life balance is important to us; we offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days, and an excellent cafeteriaAttractive salaries and success-based bonuses for all medac employeesIndividual training opportunities: Our medac academy offers a wide range of programs, including leadership training, coaching essentials, and language classesA funded pension scheme and other social benefitsWe care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselingWe promote sports and activities to improve our employees’ healthAre you looking for a new professional challenge and a job with a meaning? Become part of medac’s internationally growing team, and let’s make a difference together. We are looking forward to receiving your online application!After applying, please check your spam folder and add us and our applicant management software “Workday” to the list of trusted senders. Thank you very much.We want everyone to feel included and welcome, and we treat everyone equally. We welcome all applications, regardless of age, gender, sexual identity, nationality, religion, ideology, ethnic and social background or disability. Anyone who is part of medac is part of a diverse – and therefore strong – team.ContactDo you have any questions?
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