Associate Medical Director, Clinical Science Haemophilia
Role & Function
The Associate Medical Director Clinical Science Haemophilia is responsible for Sobi’s clinical development activities for one or more product(s)/indication(s) in the therapeutic area of Haemophilia and serves as scientific and medical expert on matters relating to the assigned development program including operational, regulatory and drug safety.
- Provide clinical, scientific, and strategic input to clinical development plans and activities, while adhering to the highest scientific and ethical standards ensuring for success;
- Act as Medical Director responsible for Sobi-sponsored studies;
- Responsibility for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and other MACS members, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable;
- May be member of the Medical Development Team and member of Clinical Study Team(s) and collaborate with the Medical Development Lead for scientific and medical development strategy;
- Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications;
- Responsible to development of clinical study protocols and reports and contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate;
- Provide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products/projects, as requested and appropriate;
- Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority’s questions to support e.g., scientific advice, IND application, marketing authorization;
- Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of Haemophilia, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A;
- To be successful in these activities, the Associate Medical Director, Clinical Science Haemophilia: o Will possess and continue to develop significant level of knowledge in the therapeutic area of Haemophilia. o Will develop productive relationships and contributions within the cross-functional headquarter team, as well as with local affiliate offices, and collaborative partners. o Will role model the highest scientific and ethical standards, and work in accordance with applicable rules and regulations with regards to scientific and medical activities.
- Required: Medical degree with specialty in Haematology or Specialized in Haematology/Haemophilia Clinical Development with minimum of 5 years pharmaceutical experience;
- Required: Solid record of accomplishment in drug development programs within haematology/Haemophilia demonstrating outstanding and intimate understanding of translating early-stage programs into the clinic and further across the clinical development chain;
- Required: Good communication skills, capable of representing the company to all audiences both internally and externally, particularly in the context of collaborations at international conferences and scientific symposia;
- Required: Good organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operations;
- Required: Good leadership skills with experience in leading cross functional teams;
- Required: Proficient level of English;
- Desired: Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making;
- Desired: Expertise in pharmacokinetics and pharmacodynamics.
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