Job Ref ID: 2019-037
Summary of Position
The Clinical Scientist, will be responsibility for the planning, implementation and daily operation of drug development projects. S/he will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our portfolio.
We are seeking a well-trained individual with strong leadership skills who is driven by science and the desire to develop novel therapies for patients. This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture. The ideal candidate will have a mastery of the drug development process, study document writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
Specific duties and major responsibilities include:
- Direct/oversee the design and implementation of early stage clinical projects and ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
- Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the long-term clinical development plan.
- Present and defend protocols and clinical development plans at internal governance forums.
- Serve as a functional area representative to cross-functional teams, providing oversight and guidance at the Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team.
- Work closely with the Medical Monitor to assess study progress, ensure proper study conduct and adherence to the protocol, and lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
- Present study updates, interim results, and final headline data to senior management as required.
- Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
- Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists
- Implement clinical R&D policies, SOPs and related directives.
- Review potential in-licensing candidates and present recommendations to Viela Leadership.
- Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
- Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
Desired Skills & Experience
- At least 5 years of experience in clinical research (in an academic, pharmaceutical company, or CRO environment) related to the design and/or conduct of clinical studies is required.
- Experience in autoimmune disease clinical development and/or translational science desired.
- Excellent oral and written communication skills; strong interpersonal and listening skills.
- Results driven and able to achieve creative and sound outcomes.
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
- Ability to make sound and timely decisions; agile in learning and action oriented.
- High level of emotional intelligence; self-driven with the ability to function autonomously with minimal direct guidance.
- Able to relate to varied level audiences across organization; able to build and lead effective teams and coach & develop team members; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; experience managing and developing others.
- Able to balance scientific & business perspectives; able to delegate effectively; strategic thinker who can provide vision and purpose for teams; demonstrates managerial courage.
Education & Minimal Requirement
PhD, PharmD, or equivalent
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