Director/Senior Director, Medical Affairs

4 weeks ago

Maryland, United States CareerBuilder Full time

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Open Position

Title: Director/Senior Director, Medical Affairs
Location: Remote
If you are interested in the below position, please send your resume to careers@tgtxinc.com

and REFERENCE THE POSITION TITLE within the subject line.
Role

The Director/Senior Director, Medical Affairs, MS is responsible for co-developing and executing the Medical Strategy. 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

Co-develop medical strategy including but not limited to identifying unmet medical needs and opportunities to educate

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

Represent Medical Affairs at cross-functional meetings as needed

Build advocacy, help organize and participate in high quality Key Opinion Leader (KOL) engagements to ensure access to valuable external expertise and insights

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

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 are essential

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 ones sleeves.

Remote based, with ability to travel (US and International) approximately 25%
Education

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

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