12 days ago
Medical Affairs who will manage the development of the Company’s medical strategy for commercial products and work closely with other Departments including Commercial leading development of the Company’s medical affairs strategy for all to be marketed products. S(he) will be responsible for designing and implementing medical strategies and tactical plans while providing thought leadership and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons and medical communication. S(he) will also work closely with the safety and pharmacovigilance personell and strategic alliance partners.
- Develop and implement the US and global medical affairs plan across all products
- Develop and Medical Affairs policies and procedures and SOPs
- Work closely with commercial and clinical development/regulatory in designing and implementing launch strategies and tactics, and life cycle planning
- Provide assessments and product opportunities and threats
- Develop strategic imperative's and tactical plans to enhance healthcare practitioner education to improve patient outcomes
- Provide leadership to the Medical Affairs team and actively lead the design and conduct of Phase IIIB/IV, trials and medical materials review
- Provide medical expertise in development of promotional materials.
- Develop strategy for review and approval of investigator-initiated studies
- Develop strategy for review and approval of CME programs
- Conceive, structure and conduct of US advisory boards and steering committees
- Foster research relationships with key research centers in the US
- Interact regularly with key medical opinion leaders
- Work with commercial colleagues to develop and implement the company’s publication strategy
- Collaborate with Commercial, Legal, and Regulatory for development and review of labeling, advertising and promotional materials
- Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features
- Contribute to coaching and training Medical Science Liaisons and related sales force personnel on company clinical, medical, and scientific matters
- MD degree required,
- Experience launching rare disease therapeutics
- Experience leading a field based medical science liaison team
- You have experience designing and executing clinical trials, preferably with GHD clinical trials
- You have an excellent understanding of the drug development process and GCPs
- Strong clinical/scientific background/aptitude
- Prior experience in meeting the high standards required for drug development within a regulated environment consistently
- Previous pharmaceuticals industry experience in a Medical Affairs leadership role
- Previous launch experience would be ideal with past success working in highly matrixed, cross-functional environment requiring excellent cross functional collaboration to achieve successful results
- Strong writing and presentation skills.
- As the job involves many stakeholders and coordination of activities both internally and externally, you thrive being a team player and are highly collaborative with executive team, colleagues, investigators, and clinical research partners.
- Excellent abilities to follow complex direction/processes under pressure and are proficient balancing multiple routine tasks simultaneously to achieve goals.
- Very strong organizational skills, with attention to detail and work well under general direction, with ability to independently determine and develop approaches to non-routine problems – a self-starter.
- Travelling: 30% per year