Edgewise Therapeutics
The Director/Senior Director of Cardiovascular Clinical Development leads the advancement of cardiovascular clinical assets, contributing to strategy, operational excellence, and execution of clinical programs. This role involves serving as a medical expert, planning clinical trials, ensuring participant safety, analyzing clinical findings, and collaborating with internal and external stakeholders to support drug development.
Key Responsibilities
- • Contribute to hypertrophic cardiomyopathy (HCM) and heart failure with preserved ejection fraction (HFpEF) clinical development strategy with an eye towards operational excellence in execution and innovation.
- • Serve as medical expert on early and late cardiovascular development programs and help plan clinical trials.
- • Test the clinical hypotheses and early proof of concept of assets.
- • Act as a sponsor medical monitor to help ensure participant safety.
- • Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, and publications.
- • Participate in internal and joint internal/external research project teams relevant to the development of new compounds.
- • Aid in the selection of Scientific Advisory Committees for compounds in development and manage/participate in advisory board discussion.
- • Contribute to clinical sections of regulatory documents (INDs, briefing documents for scientific advice, BLA).
- • Develop strategies for complex issues with potential for significant regulatory compliance impact.
- • Ensure continued regulatory compliance of products.
- • Collaborate with the Business Development function to help refine strategy and evaluate opportunities as they arise.
- • Identify scientifically and operationally strong investigators who can assist in the development of our company’s investigational compounds.
- • Develop and maintain relationships with prominent clinical investigators in his/her particular field of interest.
- • Represent the Company in various external forums as needed, increasing the profile of the Company through outstanding communication skills.
- • Read, understand, and comply with all workplace health and safety policies, safe work practices, and company policies and procedures.
- • Perform other duties as assigned by supervisor.
Required
- • MD or MD/PhD. Board Certified or Eligible in Internal Medicine.
- • Must have experience in industry.
- • Minimum 3+ years of industry experience in drug development in pharma/biotech setting.
- • Demonstrated success in overseeing clinical studies and protocols.
- • Demonstrated record of scientific scholarship and achievement.
- • Proven track record in clinical medicine and background in biomedical research.
- • Ability to develop strong cross-functional working relationships with a diverse team of colleagues.
- • Closely connects with key stakeholders globally (regulators, KOLs, universities, VCs, biotechnology companies, clinical community, patient groups, policymakers).
- • Builds a high level of trust and partnership with the Executive Leadership Team.
- • Has outstanding verbal and written communication and presentation skills.
- • Able to travel on company business about twenty (25) percent of the time to manage future or ongoing clinical research projects.
- • The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
- • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
- • The ability to set clear and challenging goals.
- • Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
- • Viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization.
- • Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
- • An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive.
- • Encourages others to share the spotlight and visibly celebrates and supports the success of the team.
Preferred
- • Subspecialty training in Cardiovascular Medicine preferred.
Benefits & Perks
- • Health benefits
- • Discretionary bonus plan
- • Stock option grants
- • Stock purchase plan
- • 401(k) with match
- • Paid time off
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:
The Director/Senior Director of Cardiovascular Clinical Development will be a key leader within the clinical organization, responsible for advancing the development of the company’s cardiovascular clinical assets. This individual will serve as a strategic partner to the Executive Director of Clinical Development and the broader cardiovascular team, contributing to clinical development strategy, operational excellence, and the consistent execution of best-in-class clinical programs across the portfolio.
Essential Job Duties and Functions:
- Contribute to hypertrophic cardiomyopathy (HCM) and heart failure with preserved ejection fraction (HFpEF) clinical development strategy with an eye towards operational excellence in execution and innovation.
- Serve as medical expert on early and late cardiovascular development programs and help plan clinical trials. Test the clinical hypotheses and early proof of concept of assets.
- Act as a sponsor medical monitor to help ensure participant safety.
- Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams relevant to the development of new compounds. Aid in the selection of Scientific Advisory Committees for compounds in development and manage/participate in advisory board discussion.
- Contribute to clinical sections of regulatory documents (INDs, briefing documents for scientific advice, BLA);
- Develop strategies for complex issues with potential for significant regulatory compliance impact. Ensure continued regulatory compliance of products.
- Collaborate with the Business Development function to help refine strategy and evaluate opportunities as they arise.
- Identify scientifically and operationally strong investigators who can assist in the development of our company’s investigational compounds.
- Develop and maintain relationships with prominent clinical investigators in his/her particular field of interest.
- Represent the Company in various external forums as needed, increasing the profile of the Company through outstanding communication skills.
- Read, understand, and comply with all workplace health and safety policies, safe work practices, and company policies and procedures.
- Perform other duties as assigned by supervisor.
The successful candidate will combine their expertise in cardiovascular clinical development with an innovative mindset to help the Company accelerate and expand their pipeline. In terms of the performance and personal competencies required for the position, we would highlight:
- MD or MD/PhD. Board Certified or Eligible in Internal Medicine. Subspecialty training in Cardiovascular Medicine preferred.
- Must have experience in industry
- Minimum 3+ years of industry experience in drug development in pharma/biotech setting
- Demonstrated success in overseeing clinical studies and protocols
- Demonstrated record of scientific scholarship and achievement
- Proven track record in clinical medicine and background in biomedical research.
- Ability to develop strong cross-functional working relationships with a diverse team of colleagues.
- Closely connects with key stakeholders globally (regulators, KOLs, universities, VCs, biotechnology companies, clinical community, patient groups, policymakers).
- Builds a high level of trust and partnership with the Executive Leadership Team.
- Has outstanding verbal and written communication and presentation skills
- Able to travel on company business about twenty (25) percent of the time to manage future or ongoing clinical research projects.
- The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
- An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
- The ability to set clear and challenging goals.
- Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
- Viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization.
- Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
- An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive.
- Encourages others to share the spotlight and visibly celebrates and supports the success of the team.
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.
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