About Edgewise Therapeutics
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
Edgewise Therapeutics is seeking an experienced, highly collaborative, and action-oriented leader to lead the development of medical strategy, planning and execution of Medical Affairs activities within cardiovascular therapeutic area. The ideal candidate will have an advanced scientific degree and extensive experience within medical affairs leadership and field-based teams. This individual will play a key role in both external scientific engagement and internal leadership working closely with the Field Director and Scientific Communication leads while contributing to the success of clinical trials of Edgewise’s cardiovascular pipeline. As a critical member of the Cardiovascular Strategy Team, this person will work closely with the leaders of Clinical Science and Development Operations to lend their own expertise to the introduction of investigations of our potential therapeutics into the clinic and assist with the dissemination of information about these studies.
Key Responsibilities:
- Develops and leads medical affairs strategy and tactics, including scientific exchange, annual Medical Affairs team meetings, field communications, and advisory boards.
- Manage the Medical Affairs budget to ensure optimal resource allocation for strategic initiatives, ensuring alignment with company financial objectives
- Leads integrated evidence planning, demonstrates full knowledge of and ability to execute approved data generation and data communication strategies and tactics.
- Develops and cultivates long-term strategic partnerships with clinical investigators, key opinion leaders, societies, collaborative groups, advocacy groups, and other healthcare collaborators
- Regularly assess the impact of Medical Affairs strategies using KPIs and performance metrics and adjust plans to enhance effectiveness and alignment with company objectives.
- Develop, maintain, and demonstrate scientific expertise and strong knowledge of cardiovascular disease states of interest, including the competitive landscape, company pipeline, clinical practice, and trial methodology.
- Leads the Investigator-Initiated Study program
- Collaborate with Field Medical Affairs leadership to identify, guide and execute disease/indication regional strategies and tactics with appropriate use of resources
- Provide strategic input into Publication and Scientific Communications, including review of congress abstracts, posters, presentation slides, manuscripts, and digital materials
- Organize and lead development of unbiased and compliance educational materials, advisory board meeting materials, and medical information response documents etc.
- Supports real-world evidence data generation and coordinates local data generation with HEOR team.
- Provides medical support for scientific symposium and medical congresses within legal and compliance regulations
- Participate/lead Medical Information processes.
- Lead the creation of tailored and robust scientific education plans for healthcare professionals and advance practice providers through tailored and enduring and live programs.
- Serve as scientific subject matter resource to Edgewise commercial personnel and other internal stakeholders, as requested
- Supports the design and conduct of clinical trials
- Collaborate closely with Commercialization, Market Access, Clinical Development, Regulatory and other cross-functional teams
Required Education, Experience and Skills:
- Master’s degree or an advanced degree in health-related field (MD, PhD, DNP, or PharmD preferred)
- Experience in cardiovascular strongly preferred.
- +12 years of total experience Advanced science degree with +7 years in cardiovascular and medical strategy or related roles within the biotechnology or pharmaceutical industry.
- Strong knowledge of Medical Affairs, with demonstrated understanding of launch planning required, with track record of successful launches in the previous 3-5 years.
- Knowledge of drug development process; medical/legal/regulatory review processes.
- In-depth knowledge of US healthcare system, including regulatory requirements, payer landscape, and healthcare provider networks
- A proven track record of strong writing and reviewing skills that are compliant with legal, requirements, local policies and procedures, including Good Publication Practices
- Demonstrated ability to present complex scientific and medical information to a range of audiences.
- Excellent communication, presentation and project management skills with an ability to develop collaborative relationships and work effectively with internal and external stakeholders.
- Ability to effectively manage medical communications agencies and/or freelancers.
- Demonstrates expert knowledge and proficiency with general office procedures such as commonly used office software (e.g., MS Office-Word, Excel, PowerPoint,).
- Ability to work effectively in a fast-paced and ever-changing environment; ability to prioritize and multi-task, and work autonomously as well as collaboratively within cross-functional teams.
- Willingness and ability to travel up to 25-30% of the time.
Salary range: $200,000 to $290,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.