A NYC-based growth-stage biopharmaceutical company with an innovative portfolio of novel, widely applicable therapeutic drug candidates, is seeking a Senior Medical Director. The Director of Medical is a key role with direct reporting to the CMO and is an exceptional opportunity for a motivated, medically-trained individual. The role includes responsibility for medical monitoring functions as well as representing the company by liaising with patient advocacy groups and KOLs, and for oversight of pharmacovigilance program. Office is located on Manhattan s west side. This is an in-person position.
Essential Functions:
- Contribute to the development and review of protocols and amendments
- Answer trial-related medical questions and interact with Clinical Operations and Regulatory Affairs colleagues, investigators, and other site personnel on medical matters.
- Review and advise on participant eligibility in consultation with Sponsors, as applicable.
- Ongoing data review (including participant, safety, coding and protocol deviation/violation listings) and advise accordingly based on significance and/ or potential trial impact.
- Review Data and Safety Monitoring Board (DSMB) reports.
- Perform other functions of a medical monitor as defined for specific projects, including but not limited to development of Medical Monitoring Plans and eCRF input or review to ensure appropriate capture of medical data.
- Perform, manage, co-ordinate and oversee pharmacovigilance activities
- Oversight of the development, review, and approval of Safety Management Plans and related safety reporting forms
- Serious Adverse Event (SAE) and other safety event medical triage, review, evaluation, and querying
- Ensure appropriate safety reporting to investigational sites, regulatory authorities, and independent ethics committees
- Advise on the appropriate management and/ or escalation of reported safety data in terms of trial endpoints, pause criteria and/ or Safety Data committees such as a DSMB, Protocol Safety Review Team (PSRT), Independent Data Monitoring Committee (IDMC) as applicable
Write/Review Appropriate Sections of:
- IND components
- Protocols
- Clinical study reports
- Safety update reports
- Publications
- Informed Consent Documents
Qualifications:
- MD degree- US Residency or Fellowship Required
- Medical writing skills.
- Ability to prioritize workload.
- Ability to work independently and unsupervised.
- Excellent judgment and decision-making skills.
- Able to communicate in English, effectively and accurately, both orally and in writing.
- Uncompromising attention to detail and the ability to think analytically.
- Excellent interpersonal skills and problem-solving ability.
- Strong computer skills, including advanced spread sheet skills, and the ability to learn appropriate software as necessary.
- Proficient knowledge of therapeutic areas.
- Expert knowledge of all SOPs, ICH GCP, SA GCP and local legal requirements, European, FDA and other relevant international guidelines applicable to clinical research.