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Associate Medical Director Clinical Science

Associate Medical Director Clinical Science

SobiMadrid, Comunidad de Madrid, Spain
Hace 24 días
Descripción del trabajo

Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team :

  • Competitive compensation for your work
  • Emphasis on work / life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments

Job Description

Role & Function

The Associate Director Clinical Science is responsible for Sobi’s clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including regulatory and drug safety.

Key Responsibilities

  • Provide clinical, medical, and strategic input to clinical development plans, while adhering to the highest scientific and ethical standards.
  • Responsible 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 clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.
  • Act as Study Physician responsible for Sobi-sponsored studies.
  • Member of the Medicine Development Team and of Clinical Study Team(s).
  • Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products / indications.
  • Responsible for the development of clinical study synopsis and protocols, 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 and reimbursement authorities.
  • 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 expertise, 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.

    • Qualifications

  • Medical Degree required. At least 3-4 years clinical experience treating patients (rheumatology / immunology preferred) and / or at least 4-5 years of solid record of accomplishment within rheumatology / immunology drug development programs demonstrating outstanding and intimate understanding of various phases of clinical trials.
  • Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making.
  • 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.
  • Good organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operations.
  • Good team-player with high personal and scientific integrity.
  • Comfortable working in fast paced environment.
  • Able to demonstrate behaviors in line with Sobi’s core values : Care, Ambition, Urgency, Ownership, and Partnership.
  • Ability to work effectively in a matrix, cross-functional setting; excellent collaboration skills; and experience working with co-development / co-commercialization industry partners would be beneficial.
  • Able to work well in a virtual environment. Proven self-management by showing initiative, good organization and willingness to be held accountable.
  • Proficient level of English.

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