About the role:
In this role, the Senior Medical Director has a critical role in the development of strategies for clinical programs and designs the trials in cooperation with key internal and external stakeholders to advance early and late clinical programs. The Senior Medical Director is a key contributor to the program teams, where he/she provides medical and technical leadership, may serve as the global clinical lead for a company asset and lead clinical sub-teams. In addition, the Senior Medical Director implements, monitors, or evaluates clinical trials from inception to completion. The Senior Medical Director will lead the study teams in interpreting trial results, in constructing study reports and to produce timely publications and scientific data presentations. The Senior Medical Director may also represent the matrix team and the organization in internal and external engagements with the scientific community, corporate partners, and regulatory authorities.
- Creates clinical development plans and clinical protocols to support product development, registration, and commercialization across all phases of drug development, presents to governance for feedback and approval.
- Partners with key stakeholders, including clinical and cross functional leads, leaders from relevant functions (biometrics, clinical pharmacology, clinical operations, drug safety, regulatory, pharmaceutical development) to advance and support the development and commercialization of pharmacological agents across their life cycle.
- Establish ongoing liaison with key opinion leaders, government officials, and healthcare organizations and ensure that significant developments in the field are identified and monitored.
- Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities.
- Supports generation of publications and expert reports, represents Greenwich Biosciences at professional meetings and meetings with authorities.
- Duties may include:
- Lead the clinical development team for one or more assets, as appropriate for its stage of development.
- Lead or participate in the development of team’s strategy as
- appropriate for its stage of development.
- Leads the development of study design by reviewing literature, precedent studies, and regulatory documents.
- Develops study synopses and supports the development of protocols and amendments as needed.
- Supports the development of clinical report forms and data analysis plans.
- Evaluates and develops feasibility plans and/or questionnaires, in collaboration with clinical operations, to determine type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
- Supports the selection and evaluation of relevant vendors and CROs.
- Provides therapeutic training and expertise to the project team.
- Assists the clinical team in selection and recruitment of investigational sites
- Provides scientific leadership and expertise at investigator, internal and external project team meetings.
- Develops and supports the execution of clinical monitoring plans, reviews data, supervises study medical monitoring and provides medical expertise to project teams during life-cycle of study.
- Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken.
- Assumes responsibility for ethical and medical, aspects of study.
- Other duties as assigned.
- Travel may be required approximately 20% of time.
- Industry experience with full understanding of safety, rules and regulations of industry.
- ≥4 years of drug development experience, preferably within the industry and with neurological or psychiatric drugs.
- Excellent oral and written communication skills and experience with publications.
- Ability to work collaboratively in a dynamic team-based environment.
- Possess a basic understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics.
- ≥7 years of drug development experience, preferably within the industry and with neurological or psychiatric drugs. Experience with pediatric programs is a plus.
- Board certification with a specialty in neurology, psychiatry and/or pediatrics.
- Active US Medical license.
- NDA/MAA/IND filing experience.