Sobi - Swedish Orphan Biovitrum AB (publ)

Medical Director, Clinical Science

Sobi - Swedish Orphan Biovitrum AB (publ)

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $190,000 - $270,000 per year

Job Level

Lead

About the role

  • 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 core members of the development team, clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.
  • Member of the Medical Development Team and 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 for 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., briefing documents, scientific advice, BLA/MAA applications.
  • 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.

Requirements

  • Medical Degree required
  • At least 4 years clinical experience treating patients and/or at least 10 years of solid record of accomplishment within 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
  • Previous experience (>5 years) working on and monitoring clinical trials is required
  • Experience working on and supporting regulatory submissions is preferred
  • Experience in Critical Care or Immunology is a plus
  • 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
  • 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
Benefits
  • Competitive compensation for your work
  • Generous time off policy
  • Summer Fridays
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical developmentclinical study protocolsstatistical analysis plansregulatory submissionsclinical trialsmedical monitoringdrug developmentscientific inputmedical affairscritical care
Soft skills
communication skillsorganizational skillsteam playercollaboration skillsself-motivatedscientific integrityleadership decision makingstrategic thinkingadaptabilityproject management
Certifications
Medical Degree