Job description

Overview

The Executive Director Head of Medical Affairs leads medical affairs strategy, project execution, clinical trials, compassionate use programs and IITs, publications, and medical communications. The ED is responsible for providing medical insight, guidance, strategy, medical review, competitive intelligence and training for commercial projects and business development programs and Market Access teams to develop compelling medical evidence to support optimal patient access to Celldex medicines. The ED works closely with clinical science and development teams to support clinical development programs and ensure medical and scientific alignment. Initially will support early phase programs as an individual contributor, but expected to grow the department as the programs reach later phases of development.
Responsibilities

• Lead company medical affairs strategy and execution including medical expert engagement and development, post-marketing clinical trials, compassionate use programs, investigator initiated trials (IITs), publications, medical education and medical communications (e.g. medical information, call center, etc.).
• Provide medical insights and guidance including strategy, medical review, competitive intelligence and training for key commercial projects
• Work closely with Market Access team to develop compelling medical evidence to support optimal patient access to our medicines.
• Provide medical support to business development opportunities
• Establish field based medical teams (MSLs) to develop and manage a thought leader network to support successful implementation of Celldex plans.
• Ensures safe and appropriate use of medicines.
• Ensure medical affairs compliance processes are established and followed

Qualifications

• Ability to hire and manage and develop home office based and field-based medical teams (may be contract positions).
• Ability to define strategy and execute short and long term medical plans, utilizing internal and external resources.
• Strong organizational and communication skills.
• Ability to work independently and as part of a team.
• Energetic self-starter, willing to be hands on.

Education/Experience:

• Medical training with 10 years of relevant academic, clinical and industry experience.
• MD preferred/PharmD, specialty training or experience in allergy, immunology, or related fields preferred
• Experience serving as a medical reviewer for commercial projects and promotional strategies.
• Experience designing, executing, and analyzing post marketing clinical studies.
• Experience with publication planning and execution
• Experience managing medical education and scientific communication
• Knowledge of relevant regulations impacting medical affairs activities
• Knowledge of drug development process

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Work Location: One location

www.colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, www.colinoncars.com is the ideal place to find your next job.