About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
• 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 support projects from Research to Proof of Concept (typically phase 2) at which point molecule may be handed to the Oncology Global Product Development for post-POC (typically phase 3) development. A major focus of the group is on new generation immunotherapies from naked immune monoclonal antibody to cell-based therapy.
• To provide and utilize innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions.
• 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
• 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 to 5-year 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
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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