Medical Director, Medical Affairs - Hematology Oncology

• Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety.
• Provide scientific and technical support for assigned products: deliver scientific presentations; develop and maintain professional and credible relationships with key opinion leaders; actively participate in relevant Brand Teams and help develop medical affairs strategies; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.

• Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access.

Key Responsibilities Include:

• • Initiates medical affairs activities focused on generation and dissemination of data supporting overall scientific and business strategy for on market products.
  • Oversees the conduct of medical affairs sponsored clinical trials: medically and scientifically accountable for resolution of safety (AE's & SAE's) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
  • Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies.
  • Provide input and support to the TA clinical development team for clinical research / development activities intended to support product registration, and for post approval commitments such as regulatory agency mandated trials.
  • Interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc...) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
  • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information.
  • Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
  • Ensures budgets, timelines, compliance requirements are factored into programs & apos ; scientific activities.
  • Can address complex problems within discipline/project or across disciplines. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
  Provides guidance to cross-functional team members to aid in the development of promotional materials.
• Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant experience in the therapeutic specialty Completion of residency and/or fellowship is preferred.
• Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia. 3+ years of experience is preferred.
• Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
• Ability to run a clinical study or medical affairs team independently with little supervision.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty.
• Must possess excellent oral and written English communication skills.
• Typically does not supervise employees but must be able to influence in a matrixed environment.
• Works mostly independently with limited guidance.
• Ex-Us: At least one further major international language is preferred.