Clinical Scientific Program Lead (all genders)

About the Role Clinical Science Program Lead with extensive experience in global clinical development across Phase I–IV, with a strong focus on autoimmune diseases, immunology, and innovative therapies. Proven track record in designing smart, integrated clinical development programs, evaluating new assets through due diligence and advancing lifecycle strategies, including indication extensions and territory expansions. Experienced in leading cross‑functional teams, delivering high‑quality data packages and driving successful interactions with regulatory authorities (EMA/FDA). Recognized for strategic thinking, scientific rigor and impactful stakeholder engagement. Key Responsibilities Lead global clinical development programs across Phase I–III trials, overseeing multiple studies and ensuring high‑quality execution, data integrity and timely delivery Design and drive efficient, integrated clinical development strategies, including Clinical Development Plans (CDPs) and Target Product Profiles (TPPs), aligned with scientific, regulatory and commercial objectives Provide strategic leadership in autoimmune and immunology indications, including lifecycle management, indication extensions and territory expansion initiatives Conduct due diligence and evaluation of new assets, supporting in‑licensing decisions through scientific and clinical risk‑benefit assessments Serve as the key medical and scientific interface with regulatory authorities (EMA/FDA), leading scientific advice interactions and supporting submission strategies Oversee development and quality of core clinical and regulatory documents, ensuring consistency and scientific rigor across all deliverables Your Profile Medical Doctor (MD), Pharmacist or equivalent life sciences degree with over five years of international clinical research experience (Phase I–III) Strong expertise in autoimmune diseases, rheumatology, immunology and pharmacology Proven experience in clinical development strategy, including design of efficient development programs, CDPs and study protocols, as well as support of indication and territory expansions Solid background in asset evaluation and due diligence, including scientific and clinical assessment of new compounds Experience with regulatory interactions and submissions (EMA and/or FDA), with strong knowledge of GCP/ICH and applicable regulations Demonstrated leadership, strategic thinking and cross‑functional collaboration skills, combined with strong analytical and communication capabilities Fluent in English; German is an asset Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits: 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 cafeteria Attractive salaries and success‑based bonuses for all medac employees Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes A funded pension scheme and other social benefits We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling We promote sports and activities to improve our employees’ health #J-18808-Ljbffr medac pharma production GmbH