Position Summary

- The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.

- Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials.

- Responsible for planning and leading the Local Health authority/ Subject Expert Committee interactions for assigned projects

- Successfully leads, plans, and executes trial-level activities for multiple trials with minimal to moderate level of supervision.

- Provides scientific and clinical leadership to the team of supporting Clinical Scientists (matrix leadership)

- Co-leads study team meetings in partnership with the GDO protocol manager; and collaborates with cross-functional study team members.

- May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)

Duties/Responsibilities

- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.

- Plan and Lead interactions with local health authorities including presentation to Subject Expert Committees

- Plan and lead the implementation of all study startup/conduct/close-out activities as applicable.

- Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)

- Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring high clinical quality (collaboration with Medical Writing)

- Site-facing activities such as training and serving as primary contact for clinical questions

- Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team

- Clinical data trend identification: provide trends and escalate questions to the Medical Monitor

- Develop a clinical narrative plan; review clinical narratives.

- Provision of information required by the Protocol Manager for the development of the trial budget, CRO scope of work, etc.

- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities

- Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

- Collaborate and serve as the primary liaison between external partners for scientific advice

Qualifications

- Medical qualification (MD in Pharmacology, Oncology or Hematology is preferred )

- 10+ years of experience in clinical science, clinical research, or equivalent

- Excellent track record of leading scientific interactions with DCGI and Subject Expert Committees

- Experience in Oncology and Hematology therapeutic areas is preferred

- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations

- Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation.

- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees

- Excellent verbal, written, communication, and interpersonal skills.

- Detail-oriented.

- Strong sense of teamwork; ability to lead team activities.

- Proficient knowledge of the disease area(s), KOLs, indication(s), and compound(s) under study (including MOA, PK/PD, biomarker & safety profile)

- Proficient critical thinking, problem-solving, and decision-making skills.

- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.

- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)

- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review, or similar data reporting tools

- Domestic and International travel may be required.