Therapeutic Area Lead, milvexian (Senior Director)

Role Summary

The Therapeutic Area Lead, milvexian (Senior Director) is based in Titusville, NJ and leads the Medical Affairs strategy for milvexian, reporting to the Chief Scientific Officer, Scientific Affairs. Requires strong expertise in cardiovascular or anticoagulation therapies with knowledge of the US market and competitors. The TAL will lead a team of Medical Directors and other medical affairs professionals to address medical and scientific issues and to ensure the appropriate use of milvexian.

Responsibilities

• The Therapeutic Area Lead (TAL), milvexian, will lead a multifaceted critical function for the company by supporting milvexian, reporting directly into the Chief Scientific Officer, Scientific Affairs. A strong insight into the cardiovascular or anticoagulation therapeutic areas and knowledge of the US market and competitors is required.
• The Therapeutic Area Lead will be an expert in medical affairs strategy development taking strong consideration to competitors and overall customer feedback, and will lead a group of Medical Directors (MDs) and other medical affairs professionals to develop overall Medical Affairs strategy for milvexian with a goal to address medical and scientific issues and to ensure the appropriate use.
• The Therapeutic Area Lead will identify and devise strategies to address crucial gaps using critical relationships across Medical Affairs, Global Medical Affairs, R&D, Regulatory, RW V&E Scientific Affairs, Commercial, and others. He/she will lead and effectively partner with relevant Alliance partner companies on those activities when necessary.
• Elevates needs for funding to relevant senior leaders
• Through MDs, IETLs and others will provide medical monitoring and medical oversight for company-sponsored Medical Affairs-led interventional and observational clinical trials.
• Oversees development and implementation of Investigator Initiated Study (IIS) strategy and assesses and supervises IIS conduct with the support of direct reports.
• Oversees development and implementation of Medical Education strategy, including multi-channel approach and CME strategies, and assesses and supervises overall medical education conduct with the support of direct reports.
• Oversees the medical support in the development of compliant promotional materials and the training of product representatives; will adequately and compliantly support Commercial functions.
• Oversees development and implementation of Advisory Board strategy and maintain relationships with external investigators and opinion leaders.
• Ensures development of robust Data Dissemination Plans including manuscripts, abstracts, publications arising from Janssen Medical Affairs studies. Supports multi-channel approach of dissemination as well.
• Supports Regulatory related activities such as the development of product monographs and responses to product inquiries.

Qualifications

• Required: A minimum of 10 years’ experience (including subspeciality training), with experience in a relevant position in pharmaceutical industry is required
• Required: Experience and knowledge of cardiovascular disease or anticoagulation, drug development, and Medical Affairs required
• Required: Strong track record in developing and implementing clinical research and medical strategies including evaluation of value-oriented research and communication strategies required
• Required: Proven ability to be customer focused and track the environment for clinical/scientific competitors and be change agile to create initiatives/strategies required
• Required: People management experience required
• Preferred: MD preferred; may consider PhD or other advanced degree

Skills

• Preferred: Budget Management
• Preferred: Business Development
• Preferred: Clinical Trial Designs
• Preferred: Collaborating
• Preferred: Corporate Management
• Preferred: Data Analysis
• Preferred: Developing Others
• Preferred: Diagnostic Imaging
• Preferred: Inclusive Leadership
• Preferred: Leadership
• Preferred: Medical Affairs
• Preferred: Medical Compliance
• Preferred: Operational Excellence
• Preferred: Quality Assurance (QA)
• Preferred: Relationship Building
• Preferred: Safety-Oriented
• Preferred: Standard Operating Procedure (SOP)

Additional Requirements

• Approximately 25% travel