US/Global Medical Director/Scientific Director, Hematology, Multiple Myeloma

About the role

Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities).

Responsibilities

• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
• Responsible from Global Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AEs & SAEs) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
• Screens, selects and drives the execution of investigator initiated studies and is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Provides in-house clinical expertise for multiple myeloma, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity.
• Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies.
• Reviews, assesses and reports applicable Adverse Events (AEs) and Serious Adverse Events (SAEs) if assigned to AbbVie conduct on clinical studies.
• Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
• May lead delivery of scientific alignment plan, brand plan, and integrated tactical plan. Develops innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally.
• Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development of others.
• May lead 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.
• Helps to drive the execution of the molecule and disease specific publication plan based on the unmet needs, evolving data and evolving treatment landscape through a cross-functional collaboration with publication lead and clinical development team.
• May 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.
• Provides scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of evolving multiple myeloma treatment landscape as well as competitive landscape, other professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource and is able to translate this info into strategic implications.
• Safeguards budgets, timelines, compliance requirements are factored into programs' scientific activities.

Qualifications

• For US/Global Medical Director: Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant multiple myeloma experience in an academic or hospital environment preferred. 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 or equivalent. 3+ years of experience is preferred. Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Ability to run a clinical study independently with little supervision. Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
• For US/Global Scientific Director: Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred. Typically, 8-10 of experience in the pharmaceutical industry or equivalent; substantial understanding of multiple myeloma required. 5-7 years of experience in Medical Affairs highly preferred. Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred. Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Ability to run a clinical study independently with little supervision. Proven leadership skills in a cross-functional global team environment. Must possess excellent oral and written English communication skills.