Intrexon Germantown , MD 20874
DUTIES AND RESPONSIBILITIES:
Facilitate generation of, author, update, and/or review key documents, including, but not limited to:
Protocol concepts, synopses, protocols, and amendments
Informed consent documents
Clinical study reports
Abstracts, posters and manuscripts
Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
Risks / benefits analysis for applicable documents.
Clinical Development Plans
Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
Provide scientific expertise for selection of investigator and vendors.
Train colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.
Provide scientific and medical support throughout conduction of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs.
Review, query, and analyze clinical trial data.
Interpret, and present clinical trial data both internally and externally.
Represent a clinical study or development program on one or more teams or sub teams.
Create clinical study or program-related slide decks for internal and external use.
Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
Contribute to or perform therapeutic area/indication research and competitor analysis.
Build strong relationships with internal experts.
Identify continuous process improvement opportunities.
Identify incremental organizational resource needs staff, budget, and systems.
Develop, track, execute and report on goals and objectives.
Support budget planning and management.
Be accountable for compliant business practices.
EDUCATION AND EXPERIENCE:
MD, within a clinical and/ scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
Minimum 3-5 years of experience and success within other biotech/pharmaceutical companies.
Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical setting
Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology.
Expert understanding of global clinical study design and drug development process.
High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
Knowledge of GCP and ICH Guidelines
Flexibility to work with colleagues in a global setting
Able to engage in work-related travel approximately 20% of time.
Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
Experience with the development and support of related SOPs and policies is expected.
Knowledge of industry standard Clinical Development IT solutions expected.
DESIRED KEY COMPETENCIES:
Executive presence; confident, positive attitude, enthusiastic and charismatic.
Value based collaborator respectful, accountable and collaborative.
Self-motivated and independently minded.
Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
Self-organizer, meticulous hands-on habits, keen attention to detail.
Impactful written and verbal scientific communication.
Successful and superior influencing skills across all levels of the organization and external collaborators.
Problem solving and risk-mitigation skills.
Appreciation of diversity and multiculturalism.
Strategic and creative thinker.
Ability to build working relations throughout the organization and with business partners to achieve business goals.
Strong time management and organizational skills.
Ability to manage multiple projects in a fast-paced environment.
Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.