- Oversee medical monitoring activities during clinical trials, including safety reviews, adverse event management, and protocol deviations.
- Lead the development and execution of one or more clinical development plans for rare disease programs, including protocol design, study conduct, data analysis, and interpretation.
- Provide medical and scientific expertise to cross-functional teams, including Clinical Operations, Regulatory Affairs, and Biostatistics, to ensure successful execution of clinical trials.
- Collaborate with key opinion leaders and investigators to drive scientific discussions and ensure the clinical relevance of study endpoints.
- Participate in the evaluation and selection of external vendors, including clinical research organizations (CROs), central laboratories, and imaging vendors.
- Contribute to the preparation of regulatory submissions, including MAA / BLA filings in EU and/or US.
- Stay abreast of scientific literature, competitor landscape, and regulatory guidelines related to rare diseases to inform clinical development strategies.
- Serve as a medical expert internally and externally, including representing the company at scientific conferences, advisory boards, and regulatory meetings.
- Medical degree (MD or equivalent) with board certification in a relevant therapeutic area, e.g. neurosciences or immunology
- Minimum of 5-10 years of experience in clinical development within the pharmaceutical or biotechnology industry. Experience in the rare disease area is a big plus
- Strong understanding of clinical trial design, execution, and regulatory requirements, preferably including knowledge of orphan drug development pathways.
- Proven track record of leading successful clinical development programs from Phase I through Phase III, including experience with regulatory submissions and interactions.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
- Flexibility to adapt to a multicultural and evolving work environment, with a proactive and solutions-oriented approach.
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Medical Director - Paris, France - Science at Work Staffing B.V.
Description
Korte omschrijving
Medior or Senior Medical Director in Clinical Sciences, based the Netherlands or EU remotelyWhat are your responsibilities?
What do we look for in a Medical Director - Rare Diseases?
We are seeking a highly skilled and motivated Medical Director to join the international Clinical Development team. You play a key role in medical monitoring, as well as designing and implementing strategies for the different clinical development programs.
Qualifications:
This position offers a unique opportunity to make a significant impact on the lives of patients while contributing to the advancement of cutting-edge treatments.
What can you expect from the company?
Our clientis a leading pharmaceutical company dedicated to advancing treatments and improving the lives of patients with rare diseases. With a strong commitment to innovation and patient-centricity, we strive to bring transformative therapies to market to address unmet medical needs.Salary and benefits Medical Director - Rare Diseases
Our client offers an excellent remuneration package, which issubject to negotiation based on the candidate's qualifications and experience.
About Science at Work
People and science come together at Science at Work. Our Talent Acquisition Experts are all high-level discussion partners with a completed laboratory and science education. We bring talent and employers together for permanent and temporary jobs throughout the Benelux.
We are part of the international Belgian recruitment organization with 1500 professionals, 20 offices in The Netherlands, Belgium, France, Germany and Switzerland we have a large span and even greater industry knowledge.
Science at Work equals quality and knowledge. Science at Work further distinguishes itself by the latest recruitment technologies, inspired recruiters and attention to people and the environment. In this way we work faster, more efficiently and greener.
Science at Work works for MLO (vocational), HLO/BASc and MSc professionals in the life sciences, pharmacy, food, biotechnology and (petro) chemistry throughout the Netherlands. We offer permanent and temporary laboratory and science jobs in microbiology, chemistry, analytical chemistry, biochemistry, sales, quality assurance, medical devices and biomedical laboratory technology.
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