Director - Clinical Research Scientist

Role Summary

The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding regulatory requirements as well as awareness across business operations, and emerging issues.

Responsibilities

• Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
• Reporting of adverse events as mandated by corporate patient safety.
• Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies.
• Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed.
• Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions.

Qualifications

• Required: An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty).
• Required: 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within Oncology and/or Hematology.
• Preferred: Breast cancer disease area knowledge.
• Preferred: Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Preferred: Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team.
• Preferred: Proven track record to bring out the best in others on a cross-functional international team. Leading by influence.
• Preferred: Proven track record to interact externally and internally to support a global scientific and business strategy.
• Preferred: Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel.
• Preferred: Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Preferred: Strong communication, both written and oral.
• Preferred: Ability to multi-task and shift priorities rapidly to meet target dates.