Medical/ Scientific Director

Working independently, the Medical/Scientific Director is capable of fully leading designated aspects of the Medical Affairs strategic planning process and its implementation on behalf of the Regional Medical Affairs Leader (RMAL) and in collaboration with her/his peers and other functions in the medical affairs team.  The scope of the role therefore mirrors parts of the scope of the RMAL role, to whom she/he is accountable. This may include the following activities:

• Plays an integral role in contributing the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/indication(s).

• Drives delivery of designated above-country elements of the MAP, e.g., Advisory Boards, Symposia, Medical Educational Events, Scientific Platform.

• Partners with commercial colleagues to optimize brand strategy, campaigns and launches in the Local Operating Companies (LOCs).

• Leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).

• Drives the development and/or approval of educational, training, and other materials and responses.

• Drives the regional congress planning and coordination from a brand perspective, including pre- and post-congress deliverables and supporting LOCs in local congress execution.

• Drives the scientific training coordination and execution from a brand perspective,

• Delivers the evidence needs for that asset on behalf of the RMAL in partnership with R&D

• Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.

Key Responsibilities

This role will provide YOU the opportunity to lead key activities as follows:

• Gathers medical insights from the Local Operating Companies (LOCs) and external stakeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and global medical affairs plans and strategy.

• Leads medical lead research activities including Expanded Access Programs

• Leads Advisory Board design and discussion ensuring compliance with SE governance and documentation requirements.

• Leads Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements.

• Inputs to the design and delivery of phase IIIb/IV studies and EAPs, including post-approval commitments, coordinating with relevant R&D technical experts.

• Facilitates preparation for the Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across LOCs.

• Develops/reviews publications/abstracts/posters related to the product, key competitors, and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained.

• Supports the RMAL in communicating effectively the clinical and market access data for their asset to the LOCs; ensures a robust understanding of risk: benefit.

• Enhances local tactical plans and shares best practices to support Launch Excellence.

• Supports the RMAL in providing medical governance oversight for the asset, including management of product-related issues with potential impact on patient safety, and medical budget management.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Medical Doctor-Board Certification or clinical and industry experience with Oncology, PhD or PharmD

• Minimum 5 years in Industry or clinical experience in the hemato-oncology therapeutic area.

• Minimum 5 years of experience in significant disease and Multiple Myeloma with therapeutic area knowledge

• Broad drug development experience with robust knowledge of GCP regulatory/ market access.

• Experience in developing, designing, and implementing expanded access program studies.

• Significant experience in Global / Regional Medical Affairs and life cycle management, including launch.

• Robust understanding of promotional codes/regulations; previous involvement in review and approval processes.

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Prior experience in multiple myeloma along with bispecific and or CAR-Ts

• Have launched multiple products in Multiple Myeloma or Hematology

• Highly developed leadership, networking, communication, intercultural communication skills and influencing skills to work effectively in a complex