Associate Medical Director / Medical Director

Tubulis GmbH; Leipzig; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading biotechnology company in Leipzig is seeking a Clinical Lead to guide the development of novel cancer therapies. The ideal candidate will have an MD or MD/Ph.D. with a strong background in oncology and clinical trials. This role includes leadership in trial design, regulatory document preparation, and overall project strategy. Join us to make a real difference in cancer treatment and grow with our innovative team.

Leistungen

Impactful work

International team

Career development opportunities

Innovative work environment

Qualifikationen

• 3+ years in pharmaceutical/biotech with biologics/ADC clinical development.
• Strong track record in global Phase I-IV trials.
• Experience with regulatory and clinical development processes.

Aufgaben

• Provide clinical leadership and strategic medical input.
• Lead development of trial and regulatory documents.
• Act as clinical lead within the trial team.

Kenntnisse

Clinical leadership

Oncology knowledge

Protocol writing

Programming in R

Ausbildung

MD or MD/Ph.D. in life sciences

Oncology Fellowship

Jobbeschreibung

About Us

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

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 :

• 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.