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Senior Medical Director, Clinical Development
Celcuity
USA
Full-time
Senior · 8–10 years experience
Onsite
Discovered 1 weeks ago
gcp
Key Skills for This Role
gcp
Full Job Posting
Responsibilities
- Assist in design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents.
- Act as a medical monitor for assigned study.
- Discuss study design with investigators and key opinion leaders.
- Provide clinical input for clinical protocol monitoring guidelines and analysis plans.
- Drive clinical database design, data collection and cleaning and oversees clinical interpretation of study data.
- Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur.
- Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling).
- Lead or assist in the development of publications – abstracts, manuscripts, slides, etc.
- In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status.
- Assist in database finalization, reviews of study results, results interpretation and CSR’s.
- Assist in planning and presentation conduct of investigator meetings and Advisory Boards.
- Oversee and manage vendor activities/deliverables as appropriate.
- Present study results, as appropriate, to medical/scientific community at meetings and in published format.
Qualifications
- Medical Doctor (MD) with experience in solid tumor clinical trials required; recent experience in breast carcinoma preferred.
- 8-10 years’ clinical development experience in the pharmaceutical or biotechnology industry (depending on title or degree).
- Phase I–III clinical trial experience, with phase 3 experience preferred.
- Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
- Working knowledge of the IND/NDA process.
- In depth knowledge of GCP/ICH guidelines.
- Strong written and verbal communication skills (fluency in written and verbal English) as well as proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
- Good organizational, time management and interpersonal skills, proficiency in computer and software skills.
- Experience with regulatory submissions is an asset.
- Preferred:
- Leadership skills include a collaborative and team-oriented approach.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
- Values-based leadership consistent with Celcuity’s core principles.
- Building team within Celcuity, as well as among Celcuity and CRO’s working together on development and execution of clinical studies.
Preferred Qualifications
- Medical Doctor (MD) with experience in solid tumor clinical trials required; recent experience in breast carcinoma preferred.
- Phase I–III clinical trial experience, with phase 3 experience preferred.
About Celcuity
Biotechnology155 employeesFounded 2012
Publicly traded commercial-stage biotechnology company developing and commercializing targeted therapies for breast cancer and other solid tumors.
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