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global clinical development physician
hace 1 hora
Mission
The Global Clinical Development Physician is an important member of the Strategic Clinical team and the Clinical Study Teams within Global Clinical Development. This role provides medical medical input and support to the study team for a given clinical development project in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional teams and under supervision of a Global Clinical Program Lead (GCPL) or a line manager.
The Clinical Development Physician may deputize as GCPL for defined parts of programs or programs of low complexity under supervision and serves as a primary source of clinical/medical accountability and oversight for the clinical study/ies.
Core Responsibilities
- Supports the Global Clinical Program Lead (GCPL) and Clinical Development Scientist (CDS) in designing clinical development plans and clinical studies
- Acts as a backup and is able to perform GCPL responsibilities under supervision for defined tasks
- Supports clinical study synopsis, study protocol, study protocol amendments elaboration in collaboration with GCPLs and CDS
- Supports GCPL and CDS in review of the scientific content of the study protocol, amendments, CSRs, ICF, CRF, as well as scientific/clinical content of key internal or external project related documents (eg. IB, briefing package for regulatory authorities, ISE, ISS, publication)
- May deputize the GCPL as member of the Global Project Team
- Provides medical support to the Clinical Study Team to address questions raised by Ethics Committees as well as questions coming from the investigators in preparation and during the study/ies conduct
- Leads medical data review, including eligibility review and safety data review
- Provides medical support for the protocol deviation review
- Partners with CDS and Clinical Operations to support clinical study/ies delivery (enrollment status, eligibility criteria and adjudication for protocol violation, evaluate need for study protocol amendment/s)
- Once clinical study/ies results are available, support the GCPL and CDS in data analysis, data review and content proposals for the publications
- Core member of the Clinical Study Team
- Builds relationships with external KOLs
Required Education And Experience
- Medical degree. Specialty in dermatology is a plus
- Prior experience in clinical studies, e.g. as (sub-) investigator, or industry / CRO experience
- Fluency in English (written and spoken), Proficiency with MS Office
Preferred Skills And Competencies
- Ability to communicate information and lead presentations in scientific and clinical settings
- Data analysis, communication, and presentations skills in team settings and in formal presentations to leadership committees both internally and externally
- Leadership skills with the ability to influence others and drive consensus building
- Analytical and problem-solving mindset
Why work with Almirall?
We are a
people-centric company
where employees are at their best, patients and customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.
Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time.
This strengthens our commitment to create a
unique work environment that helps our employees to develop their skills to fullest
and grow both professionally and as individuals.
We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions.
We are
proud of each one of our employees
, their development, and growth: they are the success of the company.
Our purpose
"Transform the patients' world by helping them realize their hopes & dreams for a healthy life".
Our values
- Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
- Courage: we challenge the status quo, we take full ownership and we learn from our success & failures.
- Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
- Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
At Almirall, it's all about people
#wearealmirall
