Medical Director - Snr Consultant
Edison-New Brunswick Metro Area, NJ
- Medical Director - Hematology/Oncology Therapeutic Area Lymphoma
Global Clinical Research & Development Hematology/Oncology
M.D. degree and medical/clinical training in Internal Medicine and 2-3 years of experience designing, leading and managing significant clinical trials Clinical training in Hematology or Oncology
2-3 years of experience in managing clinical trials in Hematology or Oncology in industry
- Position Description
- The Clinical Research Physician, Hematology/Oncology will be instrumental in supporting clinical research activities. The incumbent will have hands-on responsibility executing clinical trials, within assigned therapeutic areas, with a particular focus on medical review of phase III data in support of regulatory submission.
Responsibilities may include, but are not limited to, the following:
Under the supervision of the program leader, provide medical monitor support to company sponsored clinical trials, including efficacy and safety data review, authoring/review of narratives and authoring/review of key regulatory documents such as briefing documents and clinical components of submission dossier
Author clinical sections of IND s, Investigator Brochures, CTA s, ISS s, ISE s and clinical expert reports
Provide therapeutic area medical and scientific expertise to study teams and key stakeholders
Anticipate and plan for problems/challenges and establish contingency plans and course corrections
Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area.
Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
Effectively manage resources, funding and expenses.
Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL s.
Work independently to achieve milestones and endpoints and ensure executional excellence.
Medical expertise to review and interpret clinical data (safety and efficacy)
Strong writing skills and communication skills
Understand the skills and capabilities needed to effectively meet goals and objections.
Reinforce open-mindedness, diversity of thought, collaboration, best practice sharing and risk taking among team members and stakeholder groups.
Optimize extensive knowledge of the clinical development process and strong relationships with team members, colleagues and internal and external stakeholders to achieve results.
Handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies.
Garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.