The primary responsibility will be to provide medical support to all areas and aspects of the business and be the main medical contact regarding Difelikefalin and new products in pipeline.
The Executive Medical and Scientific Affairs Director will lead a broad range of medical affairs activities to be the launch leader from medical affairs for DFK and future launches of new products in the pipeline.
Lead the medical lifecycle activities of Difelikefalin (DFK) and new products in the pipeline.
Reporting to the VP Head of US Medical and Scientific Affairs and working closely with both the Commercial and Clinical Development groups, the Executive Medical and Scientific Affairs Director will play a key role in leading and executing the medical education and scientific development platforms necessary to support DFK’s launch.
In addition, the Executive Medical and Scientific Affairs Director will work closely with the Commercial group to provide medical strategic guidance to prepare and finalize marketing and promotional materials, sales training tools and other external communication pieces.
The position will lead and participate in various other activities related to the ongoing medical support of DFK, including the implementation of the DFK publication plan, supporting thought leader engagement activities, planning, and participating in advisory board activities, developing, and maintaining relationships with key scientific organizations, and being the US lead and representative for planning of new phase 3b and phase 4 clinical trials as these relate to life cycle management activities.
The position may also be involved in developing content and pharmaco-economic projects to support market access and reimbursement, and in supporting business development activities.
Lastly, the position may contribute to building the product label. This is to be a full-time, in-house position. These responsibilities also will apply to new products in pipeline.
- Provide Medical Affairs leadership and input to the clinical development team regarding commercial aspects of development and to the commercial team regarding the use of scientific and clinical data
- Participate as a core member in the Global Brand Team (GBT) to develop and align on global medical strategy and join leadership meetings with partner companies (e.g.: with Cara Therapeutics).
- Closely collaborate with and provide medical guidance to the managed care, health economics and outcomes research working groups
- Build evidence-based advocacy by driving and executing the publication plan, being a publications sponsor, and presenting at scientific meetings and attending professional seminars and educational programs
- Execute and coordinate the Thought Leader engagement strategy, the DFK publication plan and regularly update the scientific platform and slide compendia
- Seek medical and scientific input from Thought Leaders by driving and executing regional and national advisory board programs.
- Review and sign-off on medical and promotional materials for scientific/medical accuracy, including all promotional pieces, sales training aids, corporate presentations and press releases, publications and drug information letters.
- Work closely with Clinical Development to design and implement additional clinical studies to either expand the product label or to address any unanswered scientific and medically important questions, as appropriate
- Lead the execution of the Investigator Initiated Studies (IIS) Program after approval
- Provide education and training to Medical Science Directors and Sales Representatives as needed
- Collaborate with Global Medical Affairs team to develop and share medical resources and to plan congresses.
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
- At least 15 years of relevant medical affairs experience in the pharma/biotech industry
- Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO). Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant in another country.
- Previous experience with Launch of a product.
- Ability to travel 20%
- At least 15 years of relevant medical affairs experience in the pharma/biotech space in nephrology.
- Familiarity with GCP/ICH/FDA/OPDP (formerly DDMAC) requirements as well as clinical trial design, biostatistics, product safety, and regulatory affairs preferred.
- Prior Experience in Nephrology or Cardiology (Experience in academia, clinical, or industry setting)