Job Title
Sr. Director Clinical Development – Clinical Scientist
Job Summary
Working closely with the leaders of NKGen Biotech, the Clinical Scientist (CS) Lead will assist in the implementation of the clinical development strategy and will lead all aspects of individual Oncology program. The CS will be an integral part of the Clinical Development Team at NKGen Biotech and be part of the leadership team in clinical and strategic aspects.
General Responsibilities
- Accountable for safety across the study by real-time review of individual patient safety data, performance of cumulative safety review and timely communication about safety issues with the internal safety risk team, investigators, study staff, IRBs and regulatory authorities.
- Oversee medical monitoring activities for one or more programs
- Author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content
- Contribute to the establishment of standards for clinical documents and data review processes across Oncology Clinical Development
- Participate in interpretation of data analyses of clinical trial results and support the development of clinical study reports
- Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, annual reports, etc.)
- Serve as program clinical expert for internal and external collaborators, investigators, consultants, and contract resources
- Contribute strategic guidance and highlight clinical considerations to inform portfolio development strategies, individual study design and conduct, combination strategies, and disease area strategies
- Interpret complex clinical data and identify trends for clinical and regulatory documents consult on safety analyses, and responses to health authority queries
- Prepare for governance discussions in close collaboration with cross-functional teams and other business lines
- Participates in CRO diligence and selection; works collaboratively with the study team and CRO, and manage the trial; develops and delivers protocol training for investigator site(s), NKGen Staff, and CRO staff.
- The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- BS or other equivalent degree with demonstrated depth and breadth of knowledge and a minimum of 5 years of experience in clinical care and research in the academic, clinical practice and/or industry setting.
- Strong understanding of translational disease biology or ability to design innovative trials based on emerging biomarkers and clinical outcome measures
- At least 8 years pharmaceutical or relevant scientific/medical/clinical experience required, with at least 5 years in Oncology.
- Established track record of scientific publications and presentations
- Experience leading matrix teams with a strong reputation of inspiring and motivating high performance
- Cross-functional medicine development knowledge and business acumen
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology
- Highly effective communication skills; able to present complex data, design, strategy to groups at all levels of the organization
- Demonstrated ability to produce written scientific communications with clarity, accuracy and rigor
- Robust knowledge of Oncology treatment guidelines, therapeutic competitive landscape, clinical development process and drug approval process in major regions
- Comprehensive understanding of product and safety profiles
- In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, or other relevant guidelines and regulations
- Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
- Experience in Immuno-Oncology is preferred, but not required
- Ability to adjust behaviors and priorities based on changing environment and dynamics
- Demonstrated understanding of the detection, investigation, assessment and prevention of adverse effects of medicines on patients
- Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a clinical perspective
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!
Source: Indeed.com
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