Our client is a commercial-stage biopharma company focused on the development and commercialization of antibody-based therapeutic products for cancer treatment. Their mission is to become the world leader in developing better and safer antibody-based oncology products addressing unmet pediatric and adult medical needs.
The Director of Medical Affairs will play a pivotal role in developing and implementing medical strategies that support the company's product development and commercialization efforts. This individual will ensure that all medical affairs activities adhere to regulatory and ethical standards, and will serve as a key liaison between the company and healthcare professionals, patients, and other stakeholders.
Key Responsibilities:
- Develop and implement medical affairs strategies for product development and market access.
- Ensure all medical affairs activities comply with regulatory and ethical standards.
- Engage with healthcare professionals, patients, and other stakeholders to understand their needs and perspectives.
- Collaborate with research and development teams to incorporate clinical insights into product design and development.
- Oversee the production of scientifically accurate educational materials for healthcare professionals and the public.
- Manage the planning, execution, and evaluation of clinical trials including ISTs and IITs.
- Provide medical and scientific expertise to internal teams, such as marketing, sales, and regulatory affairs.
- Review and approve promotional materials to ensure they are scientifically accurate and compliant with regulations.
- Stay updated with the latest medical research, industry trends, and regulatory changes.
Qualifications:
- Advanced degree in a healthcare field (e.g., MD, PharmD, PhD).
- Minimum of 6+ years of experience in medical affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of regulatory requirements and compliance in the pharmaceutical industry.
- Ability to work collaboratively in a fast-paced, dynamic environment.
- Experience with oncology products is highly necessary.
