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Medical Director/Senior Medical Director

Tubulis GmbH

Medical Director/Senior Medical Director Full-time Be part of our team As a Medical Director/Senior Medical Director and member of our Clinical Development team, you will support the planning and execution of full life‑cycle development of our antibody‑drug conjugates (ADCs) global clinical trials. You will lead all clinical aspects of clinical trials, provide support to the Clinical Trial Team (CTT), ensure patient safety, and support the company in clinical development and in medical aspects of early development. You will be responsible for clinical trial execution and analysis and serve as a key member of the CTT. You will be part of a highly collaborative and cross‑functional team involved with site evaluation, study start‑up, study execution and management, and study close‑out of our trials. This position will report to the VP, Clinical and Translational Development. The ideal candidate will be based in the Boston, MA region with remote opportunities available for candidates located in MA, NY, PA, RI, NC. Please only apply if you live within one of these states or are open to relocating to Boston. Your mission Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program. Lead development of clinical sections of trial and program level regulatory documents such as protocol & amendments, imaging/pathology/DSMB charters, briefing books, BLA/MAA, ODD, breakthrough applications etc. Act as clinical lead within the clinical trial team (CTT) and support the other CTT functions such as biostats/DM/Pharmacology/PV/Clinical operations etc. Execute the clinical development strategy in accordance with GCP, ICH (International Conference of Harmonization), and Competent Authority regulations. Support the Clinical Development leadership team in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues (eg provide clinical input to DSURs). Support the Clinical Development leadership by providing medical input into the Clinical Development Plan. Contribute to development of disease clinical standards for new disease areas. Prepare and support reports on clinical trials such as abstracts/manuscripts. Support preclinical functions and the Clinical Development leadership and the Chief Development Officer (CDO) to develop biomarker strategies. Identify and mitigate risks (technical, clinical, financial) to the program. Support pre‑clinical development activities such as target Identification, asset selection; support in‑licensing, out‑licensing or partnering efforts. Maintain close communication and alignment with other non‑clinical development teams to ensure overall product goals. Develop and maintain scientific and clinical knowledge in respective areas of Interest. Your profile Qualifications: MD, MD/Ph.D., in life sciences and Oncology Fellowship training is required. 3+ years of experience in a pharmaceutical or biotechnology environment and experience in biologics/ADC clinical development. Strong track record of working within clinical teams in global Phase I‑IV trials. Experience writing protocol amendments, informed consents, and other protocol‑related documents for the operational execution of clinical studies. Holds a working knowledge of oncology with a proven track record to interpret, discuss and present efficacy & safety data relating to clinical trials. Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes such as IND, CTA and BLA/NDA filings; good understanding of relevant FDA and EMA regulations. Demonstrated ability to establish effective scientific partnerships with key partners, experience in managing KOLs and CROs, in conduct of clinical ad boards. Experience with generation of scientific publications. Preferred Qualifications: Experience with ovarian cancer or lung cancer strongly preferred. Expertise in programming in R. Why us? At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast‑growing biotech where science meets passion—and where you have the chance to grow with us. Impact that matters : Contribute to breakthrough therapies. Global mindset : Work in an international, diverse team. Grow & thrive : Develop your career in a supportive, fast‑moving environment. Innovation every day : Push boundaries with cutting‑edge science. At Tubulis, your ideas matter, your growth matters—and together, we make a difference. #J-18808-Ljbffr

Vacancy posted 4 hours ago
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