Associate Medical Director / Scientific Director, Global Medical Affairs - Oncology

Job Description

• Develops, reviews and follows up on clinical studies and medical projects initiated within the relevant therapeutic area (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.) at the regional/local level.
• All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
• Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
• May interact with and coordinates 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. May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
• May assist in scientific/medical education of 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.
• Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
• May represent the medical function on cross-functional integrated teams for medical affairs 'activities. May represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
• May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs .

Level Commensurate with experience

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
• National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred.
• Strong experience in oncology/hematology therapeutic area in either pharmaceutical industry, clinical setting or academia, highly preferred
• Minimal clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
• 1-2 years of experience is preferred.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• May possibly have performed protocol design in the academic environment or in the pharmaceutical industry and/or acted as an assistant PI or PI.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects/schedules, etc.
• Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
• Ex-Us: At least one further major international language is preferred.

Scientific Director

• Advanced degree (e.g. PhD, PharmD). Post doctorate experience highly preferred.
• Ability to provide input and direction to clinical research with appropriate supervision
• At least 10 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent
• Strong experience in oncology/hematology therapeutic area in either pharmaceutical industry, clinical setting or academia, highly preferred
• Ability to oversee a clinical research program of moderate complexity with minimal supervision
• Ability to perform and bring out the best in others on a cross-functional global team
• Ability to interact externally and internally to support a global scientific and business strategy
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols
• Must possess excellent oral and written English communication skills

• Significant Work Activities and Conditions: N/A
• Travel: No
• Job Type: Experienced
• Schedule: Full-time
• Job Level Code: D