The position serves as a key role in contributing to the scientific and medical expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various stages of clinical development. This may include clinical trial and program implementation, and oversight of all aspects of clinical development working closely with the Medical Director/Medical Program Lead and cross-functionally to effectively implement the global development strategy. In addition, this individual may be responsible for a program and the management of Clinical Research Scientists.
- Contributes to the scientific and medical expertise in a therapeutic area leading one or more complex clinical trials for one or more compounds in various stages of clinical development.
- Works closely with Medical Director and Medical Program Lead
- Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
- Authors components and key reviewer of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s)
- Contributes in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities).
- Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
- Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
- Prepare, coordinate and/or participate in internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
- Participate in the development and review of study plans and serve as a liaison to project teams and CROs
- Contribute to the development of publications in coordination with Scientific Communications
- Perform training for Investigator meetings, CRO/CRA training, SIVs as warranted
- Provides scientific and clinical leadership for Clinical Research Scientists including matrix management responsibilities as applicable
Moreover, you meet the following professional requirements:
- PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
- Minimum of 10 years of experience in clinical research with at least 6 or more years of drug development experience
- Prior oncology/hematology drug development experience required
- Proven skills from working in a project oriented matrixed team environment
- Proficiency in leading teams and activities
- Excellent oral, written and interpersonal (communication) skills
- Ability to travel to as needed