The Director, Clinical Development/Clinical Scientist will report to the CMO or other senior member of the Clinical Development team to ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Development will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The Director, Clinical Development will play a key role in the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution. Specifically, the candidate will work closely with colleagues in clinical development, clinical operations, safety/pharmacovigilance, regulatory, biometrics, biomarkers and translational research, and program leadership.

• Facilitate and execute the generation, author, update, and/or review of key clinical and regulatory documents, including, but not limited to:
  • Protocol concepts, synopses, protocols, and amendments
  • Informed consent documents
  • Investigator Brochures
  • 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 study supporting documentations and processes, g. charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc.
• Instrumental to the Clinical Development Plan Generation and Program Strategy
• Primary contact and lead for all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following:
  • Provide clinical and scientific expertise for selection of investigator and vendors
  • Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
  • Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
  • Review, query, and analyze clinical trial data
  • Serve as medical monitor or partner with (senior) medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator
• Interpret, and present clinical trial data, both internally and externally
• Create clinical study or program-related slide decks for internal and external use
• Represent a clinical study or development program on one or more teams or sub teams
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings, engage advocacy groups
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Build strong relationships with internal experts.
• Identify continuous process improvement opportunities and help define/optimize standards and processes.
• 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.

Educational requirements:

• MD, PharmD, or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.

Experience and skill requirement:

• Minimum of 10 years of experience and success within other biotech/pharmaceutical companies.
• Previous participation in a clinical development program is essential, including involvement in most 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 scientist or similar role.
• 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 from discovery to registration and post-marketing.
• 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 25%
• Demonstrated success in working in a cross-functional environment
• Experience with the development and support of related SOPs and policies is expected.
• Knowledge of industry standard Clinical Development IT solutions expected.
• Executive presence.
• Values based collaborator – respectful, accountable and collaborative.
• Ability to relate and work with a wide range of people to achieve results.
• 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.
• Confident, positive attitude, enthusiastic and charismatic.
• Appreciation of diversity and multiculturalism.
• Strategic and creative thinker.
• Ability to work independently and 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, PowerPoint, Excel, etc.
• must be able to travel as job requires which can vary (generally around 20+%)