ROLE SUMMARY
To develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To work collaboratively with the functional groups within Oncology Clinical Development.
To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials.
To provide and utilize innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions.
ROLE RESPONSIBILITIES
Provides leadership to the clinical function for preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan, and regulatory documents.
He/she will closely work in a matrix team environment, including other clinicians, statisticians, clinical pharmacologists, translational biologists and others at an international level. The candidate will work on at least two clinical projects and will support the development and provide consultation regarding multiple research projects.
Provide administrative and technical oversight of clinical function within his/her Group
Ensure that all activities are conducted in compliance with relevant regulatory requirements.
Monitor and report on implementation of Global clinical initiatives in his/her group
Develop charters, resource utilization and project plans to achieve clinical project -specific goals
Implement site organizational design and develop succession planning for clinical area.
Develop people, including recruitment, retention, and career development as directed by Oncology Clinical Development Head.
Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader. As appropriate, the Senior Director may delegate these responsibilities to a physician study clinician identified in the SRP.
Be accountable for clinical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects.
Implement strategies to ensure that the clinicians are collaborative, strategic partners with scientific and clinical colleagues.
Implement strategies to ensure appropriate consistent processes in strong collaboration with associated RU partners.
Develop effective collaborations with Clinical Leads in Oncology Research & Development and Global Product Development organizations, and external regulatory, industry, professional and academic organizations.
Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
Implement aligned strategies and consistent processes to optimize the use of corporate standards
QUALIFICATIONS
Requires MD/PhD or MD and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting.
Prior specialized training in Medical Oncology; Board Certification in Oncology is desirable
At least 3 or more years experience in the pharmaceutical industry with a track record in early phase drug development through to phase 2 Proof of Concept.
Experience in the development of Immuno-therapeutics in Oncology
Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills
Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
Capacity to adapt to a fast-paced and changing environment
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