(Senior) Medical Director, Clinical Development

hace 4 semanas

Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Location: Barcelona, Spain

Job reference: R-200424

Date posted: 05/22/2024

**(Senior) Medical Director, Clinical Development Sciences**

**Reports to**:Executive Director, Clinical Development - RDM

**Location**:Barcelona,

**This is what you will do**:
As a (Senior) Medical Director, Clinical Development Sciences you will be a key component of the Project Team, working synergistically with the global project team lead and clinical team as the expert in medical scientific aspects of the drug and its development during clinical phase. The nature of this role may require working across projects and diseases.

The key accountabilities will include driving components of or the whole clinical programme strategy for individual projects, as well as the overall concept and design of clinical trials within Alexion, Clinical Development Team. You will also be the scientific leader with regards to the development, interpretation and implementation of new endpoints.

For Alexion, we work across multiple rare diseases in specialities focused on Endocrinology, Neurology, Hematology, Cardiology, Nephrology, Pediatrics and Oncology. We are now looking for a new colleague in the growing disease area covering rare endocrinology, metabolic bone disease and rare oncology.

You will be familiar or become familiar with relevant Regulatory guidelines for drug development for the key Endocrinology and rare bone diseases, as well as current treatment guidelines, relevant competitor trial designs and data as these are continually evolving. As such this will enable you to build novel and innovative approaches cross all phases of Clinical development, including Experimental Medicine studies generating data for Go/NoGo decision making to Phase 3 registrational studies

Additional tasks may include the set-up, design, conduct, reporting and regulatory submission of clinical trials; participation and leadership of cross-functional workstreams within and outside of Alexion. Finally, as a Medical Director you will play a crucial role in leading cross-project activities to direct Rare disease Clinical Development Strategy.

**You will be responsible for**:

- Guide clinical science aspects of the Clinical Development Plans (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product claims / profile
- Lead clinical scientific input to the set-up, design (target population, translational biomarker selection and low reference value/target value characterization for decision making), study analysis planning and reporting as well as regulatory submissions
- Initiate and support key contacts with opinion leaders, and help develop alliances as appropriate
- Write and check content and quality of product related publications and input to development of publication strategy
- Follow important developments and trends in the clinical & scientific literature to provide value and direct strategy across Rare Disease Clinical Development

**You will need to have**:

- We believe that you hold a Medical or Biomedical PhD or is a MD with a subspeciality preferably in Internal Medicine, Pediatrics, Endocrinology, or Oncology with many years in clinical practice
- You have several years of clinical drug development, medical affairs or medical research experience within a pharmaceutical company environment. You also possess a degree of specialist knowledge of the medical and scientific activities related to a particular therapeutic area, in this instance, preferably Endocrinology.

**We would prefer for you to have**:

- A good understanding of more than one development function
- Phenomenal interpersonal skills
- Excellent verbal and written communication skills in English
- Ability to acquire and assimilate knowledge in different disciplines, diseases and therapeutic areas
- Share our values to put patients first, follow the science, do the right thing and play to win
- A curious and entrepreneurial mindset

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