Senior Director, Clinical Development
Sobi - Swedish Orphan Biovitrum AB (publ)
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇮🇹 Italy
Visit company websiteJob Level
Senior
About the role
- Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standards
- Design, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other cross-functional teams, as applicable
- Act as Study Physician responsible for Sobi-sponsored studies if required: responsible for the development of clinical study synopsis and protocols, contribute to the statistical analysis plans, perform medical monitoring, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate
- Interact and consult with key opinion leaders and patient representatives, and lead advisory boards to define the clinical development strategy and inform the clinical trial design
- 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 across multiple geographies.
- Represent the clinical function in meetings with Health Authorities.
Requirements
- Medical Degree
- Specialty in cardiology, lipidology, endocrinology or relevant previous clinical development experience (+7 years)
- Relevant global clinical development experience in the Pharmaceutical Industry (+10 years)
- Previous experience in interactions with major Health Authorities
- Solid record of accomplishment in drug development programs within the relevant therapeutic area demonstrating outstanding and intimate understanding of translating early stage programs into the clinic and further across the clinical development chain
- Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making
- Demonstrated ability to build and execute strategic and tactical development and medical plans
- Experience and ability to engage with key internal and external stakeholders
Benefits
- Flexible
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical development plansclinical study synopsisprotocol developmentstatistical analysis plansmedical monitoringregulatory submissionsIND applicationmarketing authorizationdrug development programsclinical trial design
Soft skills
strategic planningoperational expertisestakeholder engagementleadership decision makingconsultationcollaborationcommunicationadvisory board leadershipinterpersonal skillsproblem-solving
Certifications
Medical Degree