Director/Sr. Director, Medical Affairs

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Title : Director / Senior Director, Medical Affairs

Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.

Location : Remote / East Coast Preferred

If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases.

In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).

TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features.

TG Therapeutics has offices located in Morrisville, NC, New York City, and Edison, New Jersey. For more information, visit www.tgtherapeutics.com.

Role

The Director / Senior Director, Medical Affairs, MS is responsible for co-developing and executing the Medical Strategy. One of the core focuses of this role is to build and develop effective health economic and outcomes research strategies to support TG’s business needs.

Additionally, this role helps to drive data generation (Phase 4, registry, ISTs, sponsored research), medical communication and insight generation, working with medical functions (medical strategy, medical operations, medical information, publications, field-based medical team) and cross-functionally (commercial, market access / HEOR, commercial operations) to meet goals and objectives.

This position reports to the Vice President, Head of Medical Affairs.

Key Responsibilities

• Build advocacy, help organize and participate in high quality Key Opinion Leader (KOL) engagements to ensure access to valuable external expertise and insights.
• Represent Medical Affairs at cross-functional meetings as needed.
• Co-develop medical strategy including but not limited to identifying unmet medical needs and opportunities to educate.
• Liaise and partner with the Medical Advisory Committee.
• As a content expert, review abstracts, publications, medical information letters, internal / external educational materials, and other medical documents as needed.
• Review and critically appraise research proposals (ISTs, collaborative research).
• Provide medical expertise to and lead cross-functional teams and projects, as needed.
• Review and support authoring of regulatory interaction documentation, as needed.
• Provide guidance and training to affiliates and cross-functional partners as needed.
• Identify, secure, and oversee necessary budget for workstreams.
• Manage vendors and budgets to execute on agreed-upon tactics and projects often executing on multiple projects simultaneously.
• Maintain a thorough understanding of disease biology, scientific data, and competitive data in order to develop scientifically rigorous and high-quality products and programs.
• Other responsibilities within medical affairs may be assigned.
• Work as appropriate with legal, compliance, and regulatory functions to ensure all projects meet regulatory and compliance standards.

Professional Experience / Qualifications

• 5-10 years experience in Medical Affairs; MS experience preferred.
• Proven track record of successful medical strategy and execution.
• Experience in health economic and outcomes data generation and evaluation.
• Ability to interact and communicate openly and effectively with senior leadership, external key opinion leaders, and commercial and development team members.
• Demonstrated ability to work independently.
• Ability to interpret and organize highly complex scientific data, including experience reviewing clinical trial data and output from statistical analysis programs.
• Experience working closely with KOLs and investigators.
• Strong analytical skills, especially with regard to understanding and interpreting scientific and clinical research and literature.
• Must have strong project management skills and ability to successfully manage multiple assignments on time with high quality.
• Advanced computer and Internet skills, including knowledge of MS applications such as Word, PowerPoint, and Excel; PubMed; Reference databases.
• Adept, nimble, energetic and comfortable in a fast-paced, dynamic and collaborative environment.
• Capable of taking a hands-on approach and willing to roll up one’s sleeves.
• Remote-based, with ability to travel (US and International) approximately 25%.

Education

PhD, MD, PharmD, or other relevant advanced degree required.

TG Therapeutics is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.

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