Senior Medical Director, Clinical Development
J
JobgetherBiotechnology
USFull-TimeDirector
Salary$343,000 - $365,000 USD
Apply NowOpens the employer's application page
Job Details
- Experience
- 4+ years of clinical development experience
- Required Skills
- GCP
Requirements
- MD or equivalent medical degree required.
- 4+ years of clinical development experience within the pharmaceutical or biotechnology industry.
- Experience supporting immunology and inflammation (I&I) indications, with rheumatology experience strongly preferred.
- Experience with antibody therapeutics and innovative biologic therapies preferred.
- Proven experience designing, executing, and interpreting clinical trials.
- Strong understanding of clinical trial methodology, statistics, GCP requirements, and global regulatory processes.
- Experience preparing regulatory submissions and interacting with health authorities.
- Ability to provide strategic medical guidance and collaborate effectively with multidisciplinary teams.
- Excellent communication, leadership, and interpersonal skills with the ability to influence internal and external stakeholders.
- Strong project management capabilities with the ability to prioritize and manage complex initiatives in a fast-paced environment.
Responsibilities
- Provide strategic clinical leadership and medical expertise for the development of innovative antibody-based therapies in rheumatology and related immunology indications.
- Contribute to clinical development strategies, including study design, protocol development, execution planning, and interpretation of clinical trial results.
- Support proof-of-concept and later-stage clinical programs by providing medical guidance throughout the development lifecycle.
- Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, Safety, and other development functions to ensure effective trial execution.
- Provide medical and scientific input for regulatory documents, including IND submissions, investigator brochures, clinical study reports, and health authority responses.
- Ensure compliance with global regulatory standards, Good Clinical Practice (GCP), and applicable requirements for clinical development activities.
- Participate in safety monitoring activities, data review processes, and risk assessments to protect study participants.
- Represent clinical development efforts in discussions with investigators, key opinion leaders, regulatory agencies, and other external stakeholders.
View Full Description & ApplyYou'll be redirected to the employer's site
