Medical Director Medical Safety and Clinical Development Remote
Medical Director Medical Safety and Clinical Development Remote
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Job Description
Overview:
The Medical Director Medical Safety and Clinical Development will play a key role on crossfunctional teams responsible for the design implementation monitoring analysis and reporting of studies conducted for the clinical development programs. The successful candidate will have direct medical responsibility for creating clinical development plans designing clinical studies writing protocols providing CRO oversight and safety monitoring of clinical programs. The Medical Director Medical Safety and Clinical Development will contribute collaboratively toward the clinical aspects of research and earlystage development programs providing insight into treatment indications patient populations study designs and overall development strategies.
The Medical Director Medical Safety and Clinical Development will report to Chief Medical Officer and is responsible for supporting clinical development functioning as the medical lead and medical monitor for clinical trials and working with crossfunctional multidisciplinary study teams on clinical trial strategy design and . Theidealcandidate will have experience as a medical monitor in early to latestage clinical trials.
Ideal candidate would be based remote in eastern time zone.
Responsibilities:
- Contribute to the development and of comprehensive clinical development plans for Glycominess development programs. Offer expert clinical advice drawing on extensive clinical knowledge. Will review clinical study data and prepare reports protocols and development plans. Collaborate with early development research teams on clinical aspects and disease indications
- Serve as a medical expert in the company staying current with the latest research and medical advancements in the fields being studied
- Contribute to the design and oversight of clinical trials develop study protocols case report forms and informed consent documents ensuring they are conducted in compliance with regulatory standards and ethical guidelines
- Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities including INDs NDAs and BLAs. Collaborate with study team to prepare and complete clinical study reports investigators brochures and Data Safety Update Reports.
- Contribute to the Board meeting preparation including the Board of Directors Data Safety Monitoring Board and Clinical Advisory Board.
- Provide medical oversight for current and future clinical trials including safety monitoring data analysis and interpretation of clinical trial results
- Build and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the companys scientific and clinical objectives
- Collaborate closely with other departments such as clinical operations technical operations/CMC translational research and regulatory affairs to ensure alignment on program objectives
- Lead the development of scientific publications presentations and educational materials related to Glycomines programs
- Provide medical diseasespecific and development perspective into specific research programs or broader research initiatives
- Support startup activities (informed consent forms eCRF design etc. related to the assigned clinical studies
- Serve as primary medical point of contact for sites and PIs for the assigned studies as applicable
- Interface with international regulatory authorities as appropriate in support of the development objectives for the compound or program
Qualifications :
- M.D./DO or equivalent with rare disease pediatric or neuroscience experience preferred.
- Board certification in a specialty is highly desired
- 5 years experience as a medical monitor in the pharmaceutical industry experience including time managing clinical trials and/or clinical development program(s)
- Experience working collaboratively within a multidisciplinary team of colleagues and proven ability to interact with external experts and investigators
- Experience in earlystage development programs
- Demonstrated command working with FDA MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Effective oral and written communication skills are required as are excellent interpersonal skills with demonstrated ability to work with a small growing team. Marked proficiency in clinical/medical writing
- Experience designing mid and latephase clinical trials and comfortability with advanced clinical trial design and statistical methodologies
- Capable of analyzing research data and publications; working knowledge of biostatistics; working knowledge of GCP scientific and clinical research methods and clinical study design
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
