Global Clinical Lead (m/f/d)

Tubulis

Global Clinical Lead (m/f/d)

Tubulis

Munich, Germany

About Tubulis:

The development of novel and 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 worldwide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

Be part of our team:

We are looking for a proactive and committed Senior MD, MD PhD or PhD with strong experience in global clinical development of Biologics such as Antibody Drug Conjugates (ADCs), to drive and lead the global clinical development strategy of TUB-010, a novel CD30-ADC, and to help develop the emerging pipeline of Tubulis. This GCL will report to the CMO.

Responsibilities:

  • Lead and perform global clinical activities for TUB-010, including further development of product strategy, advisory boards, protocol writing and amendments, trial conduct/quality control/analysis and publications;
  • Write and review documents for regulatory purposes such as INDs, CTAs, BLAs, ODDs, breakthrough applications, safety reports;
  • Execute clinical plans for the development of TUB-010 as required by GCP, ICH (International Conference of Harmonization) and Competent Authority regulations;
  • Identify and mitigate risks (technical, clinical, financial) to the program;
  • Support pre-clinical development activities such as target identification, asset selection; support in-licencing, out-licencing or partnering efforts;
  • Support CMO in building up a global clinical development organization; people leadership, goal setting, supervision of goal achievement;
  • Represent the company as the clinical expert before international regulatory authorities as well as business partners;
  • 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;

Requirements:

  • MD, MD Ph.D., or Ph.D. in Life Sciences with masters´s degree and relevant additional area experience;
  • English fluent written and spoken;
  • Several years of relevant experience in a pharmaceutical or biotechnology environment and experience in biologics/ADC clinical development;
  • Track record of leading clinical teams working with global Phase I-III trials;
  • Experience in managing KOLs and CROs, in conduct of clinical adboards and proven track record of publications;
  • Track record of positive team leadership, people management, goal setting and reliable goal achievement;
  • Experience and track record with international IND, CTA and BLA/NDA filings; good understanding of relevant FDA and EMA regulations;
  • Proactive team player, striving to find best solutions in a collegial team environment;
  • Self-organized with proven project management skills.

What we offer:

Besides an exciting working and team environment which is guided by the common goal to develop new medicines that will help patients in need, we offer a competitive salary and support for your personal and professional development.

Please send a digital copy of your application including a CV, a comprehensive letter of motivation, a summary of your experience and your availability to career@tubulis.com. We are looking forward to your application.

Don't forget to mention EuroScienceJobs when applying.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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