Medical Director/Senior Medical Director, Early Clinical Development
Our client is a biotech company. They have asked us to assist them in their search for a Medical Director/Senior Medical Director, Early Clinical Development.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Develops and implements clinical development strategies/plans for early phase assets in oncology and non-oncology indications as part of a cross-functional project team.
- Translates assets from preclinical development into the clinic, and will serve as the medical monitor for Phase 1 clinical trials.
- Works closely with project teams to identify preferred therapeutic directions and patient selection strategies.
- Develops deep understanding of the clinical and competitive environment and work with teams to develop target product profiles for projects in both research and development.
- Serves as the medical lead for early phase clinical protocols; responsibilities to include leading the review and interpretation of trial data.
- Partners with Clinical Operations and PV on clinical trial conduct and monitoring, including GCP, patient eligibility, safety monitoring, AE and SAE tracking and reporting, and protocol deviations.
- Supports timely and high-quality cleaning, analysis, interpretation and communication of data in ongoing and completed studies.
- Co-authors clinical regulatory documentation and other communications, including IND, IB, annual reports, CSR, abstracts, manuscripts, and presentations.
- Participates in regulatory authority interactions as necessary.
- Develops productive relationships with external key opinion leaders and investigators and leads/participates in investigator meetings, advisory boards, and site visits.
- Works and partners with internal and external (CRO, investigator) stakeholders.
- Adheres to and implements quality standards and SOPs in clinical development.
- Provides medical oversight and clinical guidance into clinical protocols, Investigator Brochures, Informed Consent Forms, and Clinical Study Reports.
- M.D. with postgraduate training/certification/fellowship is required. Medical oncology, immunology, and/or urology is strongly preferred.
- Candidates that have early clinical development experience in the pharmaceutical or biotech industry in oncology or immunology with broader medical training will be considered.
- At least 3 years of experience in clinical development in the pharma/biotech industry is strongly preferred.
- Development experience in oncology, immuno-oncology, and/or urology is strongly preferred.
- Requires thorough understanding of GCP and international regulations applicable to clinical development.
- Track record of designing and interpreting development plans and clinical studies is required.
- Must have experience with the design and conduct of Phase 1-2 clinical studies.
- Ability to review and understand the emerging safety and efficacy profile of the drug candidate is required.
- Must have the demonstrated ability to present clinical data, study plans, and tactics clearly and accurately to internal and external stakeholders.
- Prior experience working with biomarkers is a plus.
- Requires ability to prioritize and manage multiple responsibilities simultaneously.
- Ability to work efficiently in a team-oriented and interdisciplinary setting; willing and open to contribute to the team in a flexible and adaptable manner is required.
- Must have the ability to communicate clearly and efficiently, both verbally and in writing.
- Excellent presentation skills are required.
- High degree of accuracy and attention to detail with a focus on driving quality results is required.
- Requires good judgment/analytical thinking capabilities.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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