Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as:
- Health-care professional/provider interactions.
- Generation of clinical and scientific data.
- Educational initiatives (medical education, data, guidelines and value proposition)
- Safeguarding patient safety.
- Collaborate with R&D and clinical development teams to support product development.
- Works closely with marketing and commercial teams to provide medical input into core brand strategies, and to support medical/marketing activities and market access.
- Provide scientific and technical support for assigned products.
- Deliver scientific presentations.
- Develops and maintains professional and credible relationships with, key opinion leaders
- Actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products
- Provide relevant scientific and technical training internal and external stakeholders.
Key Responsibilities Include:
- Support the local medical affairs plan for product life cycle management.
- Responsible for timely execution of medical affairs plan within budget.
- Collaborate with internal stakeholders (R&D, commercial, regional/other affiliates medical teams) and external stakeholders (key opinion leaders, advocacy and cooperative groups).
- Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders).
- Represent DS at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with key opinion leaders.
- Establishes and approves scientific materials scientific rational, design of local concepts/protocols and study results reports across different oncology products.
- Supports medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serves as the scientific team interface for key regulatory discussions.
- Assists with the scientific review, development, approval, execution and communication of affiliate medical affairs sponsored or supported clinical research activities.
- May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the Oncology therapeutic area or Medical Affairs function.
- Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
- Ability to work independently.
- Medical Doctorate (M.D.) degree or equivalent with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
- Minimum of 2-5 years of Medical Affairs and/or research and development experience in the biotech/ pharmaceutical industry. 5 years of experience is preferred.
- Must have an in-depth understanding of Medical Affairs role and process.
- Proven leadership skills in a cross-functional team environment.
- Ability to interact externally and internally to support the business strategy.
- Good knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Expert knowledge in Oncology therapeutic area.
- Must have an understanding of Pharmacovigilance practices for Clinical Development
- Ability to interact externally and internally to support global business strategies.
- Strong understanding of the pharmaceutical business.
- Must possess good oral and written English communication skills.
- Must have an in-depth understanding of the Clinical Development process for Phase I-IV