Description
Reporting to the Chief Medical Officer the position is responsible for helping to establish the oncology development, working collaboratively with members of the development team in establishing the clinical development for one or more oncology compounds anywhere from the pre-IND setting to pivotal trials and registration, partnering with research colleagues in assessing nonclinical candidates, and working with business development colleagues in assessing potential drug candidates for in-licensing. The position is also accountable for medical monitoring and patient safety and to provide medical guidance during the design, execution, and reporting of clinical studies. The candidate will work within the project team structure, sitting on core project teams to guide strategy, and working within relevant sub-teams to ensure tactical alignment and execution.The optimal candidate will demonstrate leadership qualities with significant knowledge and experience in developing Phase 1 & 2 protocols, analyzing pharmacokinetics, safety and efficacy data and advancing drug candidates through preclinical, clinical stages, BLA/NDA submissions, and Advisory/Scientific Committee Meetings. The candidate will have authored relevant sections of regulatory submissions for INDs, CTAs and global filings and, ideally, will have an established track record of publishing articles and abstracts in professional journals.Responsibilities
- Apply subject matter expertise towards formulation of clinical development plans, including selection of the proof of concept indication.
- In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine), is responsible for the design and authorship of study protocols and interpretation of clinical study data.
- Conduct medical monitoring and data listing reviews
- Work closely with Clinical Operations colleagues on study implementation and oversight, which includes site and CRO selection and investigator meeting preparation.
- Accountable for safety across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
- In conjunction with Development colleagues, prepare strategy presentations, present and discuss data at relevant team, governance, external consultant, KOL, and regulatory meetings.
- Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
- Participate in preparation for and conduct of meetings with Healthcare Authorities
- Participate in the development and delivery of protocol training for investigator site and staff.
- Educate team members and vendors on the molecule and disease area and participating in internal continuing education activities
- Contribute to the clinical development plan for one or more compounds, including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go/no-go development decision criteria
- Assume the clinical leadership role for projects, representing the medical function on the project team and representing the team for medical discussions with the Development Committee
- As a member of the project team, interface with Statistics, PK/PD, Regulatory, Clinical Operations, Diagnostics, Translational Medicine, Project Team Leadership and Management and other members of the extended project team(s).
- In conjunction with the Clinical Operations, is responsible for the on-time and within-budget execution of protocols.
- May have functional responsibility for other clinicians or clinical scientists assigned to the project and may supervise and develop other colleagues.
- Organize and prepare for Advisory Board meetings
- Act as clinical representative for in-licensing activities such as due diligence reviews, reports, and development strategies.
- MD with a minimum of 8 years of demonstrated knowledge and experience in clinical research in an industry setting.
- Oncology training required with 3-5 years in practice
- Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Demonstrated scientific productivity (publications, abstracts, etc.).
- Proven scientific writing skills and good communication skills
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