Our client is seeking a Director of Clinical Development!
This position is responsible for the strategic clinical leadership for clinical development and medical affairs activities in support of the early and late-stage development portfolio in Immuno-oncology. This role requires an individual with strong communication and leadership skills, as well as the ability to build strong relationships with key stakeholders in R&D, Medical Affairs, Business Development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific partner who can readily bridge between a cutting-edge research environment and a fast-paced clinical and product development organization. The successful candidate is expected to help drive effective pre- launch clinical development and medical affairs activities and to represent the department and programs at internal and external meetings. The individual should also have experience in regulatory affairs working with CBER on immunotherapy
- Provide exceptional scientific and regulatory expertise and collaboration within the medical team, to your peers within the group, and to the organization in general.
- Contribute to the formation, refinement and execution of medical strategies and tactics including early Phase 1b/2 and late- stage 2/3 including Investigator-Initiated Study and/or company sponsored studies and ensure medical plans optimally are integrated into Life Cycle Management (LCM) through appropriate collaborations
- Establish and maintain relationships with key opinion leaders, investigator sites, cooperative groups, professional societies in oncology, patient groups, and external consultants.
- Ensure medical and product information is provided in compliance with relevant SOPs and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers
- Contribute to the development of a strategic and robust Medical Advisory Board plan that aims to enhance product knowledge and to inform on clinical practice patterns and gaps
- Assist in the preparation publications of clinical study data and maintain a publication plan for our oncology portfolio.
- Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
- Excellent oral and written communications with ability to present data to all levels of audiences.
- Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Strong capability of strategic thinking and proposing innovative solutions to issues.
- Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.
- Minimum of 8 years of experience in clinical research working in a pharmaceutical, biotechnology or related environment.
- Working knowledge of Clinical Drug Development
- Working knowledge of Regulatory requirements as pertained to biologics
- Working knowledge of Good Clinical Practice (GCP).
- Ph.D. degree preferred (Immunology or Oncology).
Qualified Candidates, Please Send us your CV
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