Edgewise Therapeutics

You will guide the company's Cardiovascular efforts in several areas: Scientific Communications (Publications/Data Dissemination), RWE and HEOR, Medical Communications (Congress planning, Advisory Boards, Medical Education), US & Global KOL Strategy and Development as well as eventual MSL team buildout and leadership.. The senior leader, Cardiovascular Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, market preparation and launch readiness, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance.. Degree in pharmacy or advanced degree in science/medicine (MD, PhD, MD/PhD, DNP, or PharmD). Able to translate corporate strategies and objectives and apply to medical/scientific communications, as appropriate.. Ability to represent the needs of a broad range of stakeholders in development of real-world evidence strategy and tactics.

director medical affairs

<p>About Edgewise Therapeutics</p>
<p>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.</p>
<p>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!</p>
<h3>About the Position</h3>
<p>Edgewise Therapeutics is seeking an experienced, highly collaborative, and action-oriented leader to lead the Global Cardiovascular Medical Affairs team. Partnering with cross-functional stakeholders, this individual will identify and integrate the unmet needs and perspectives into product and Cardiovascular Franchise Medical Affairs strategies with a focus on external stakeholder engagement and information sharing, and the tools to support both.</p>
<p>You will guide the company's Cardiovascular efforts in several areas: Scientific Communications (Publications/Data Dissemination), RWE and HEOR, Medical Communications (Congress planning, Advisory Boards, Medical Education), US & Global KOL Strategy and Development as well as eventual MSL team buildout and leadership. Given the importance of direct patient and clinician input into our work to inform us of their unmet needs and for them to be aware of the groundbreaking science being developed at Edgewise, the person in this role will also engage externally and build trusted relationships with Thought Leaders, Patient Advocacy Groups, and Scientific Societies through scientific exchange and education/research partnerships.</p>
<p>This individual must be a natural leader with proven experience in leading and collaborating with teams and individuals in a global, matrix environment. It will be imperative that the candidate who fills this role is self-motivated and willing to engage in both strategic and tactical work, particularly in the early years as the company grows. As novel drug development in the Edgewise Cardiovascular Therapeutic Area grows, this leader will be expected to build a highly effective team of employees and/or utilize vendors to accomplish the Medical Affairs functional goals.</p>
<p>The senior leader, Cardiovascular Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, market preparation and launch readiness, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance. As a critical member of the Cardiovascular Development 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.</p>
<h3>Essential Job Duties and Functions</h3>
<p>This function is responsible for building strategic medical communications and evidence-based content and information resources in collaboration with the CDO. The Senior Leader of Medical Affairs will be responsible to work cross functionally with scientific leaders to manage the publication process and scientific congress planning, and contribute to a broad range of Medical Affairs activities, both internally and externally facing content, including the support of Medical Information and KOL mapping related activities until designated functions are built out.</p>
<h3>Job Responsibilities</h3>
<ul>
<li>Lead, and as appropriate to the progress of clinical development programs, build a world-class global Cardiovascular Medical Affairs function and infrastructure. This will include cross-functional interactions with existing personnel in Musculoskeletal Medical Affairs and hiring qualified functional leaders and/or consulting with external support to implement and execute the medical affairs strategic plan.</li>
<li>Cardiovascular Scientific Communications:</li>
<li>Create the process, plan, and manage the development and submission of medical and scientific publications (including abstracts, posters, oral presentations and manuscripts) via collaboration with internal and external stakeholders in accordance with timelines as set in publication plans.</li>
<li>Revise the Edgewise Cardiovascular Scientific Communication Platform as appropriate to the evolving knowledge of the scientific basis of our pipeline molecules' therapeutic actions.</li>
<li>Develop and update an Edgewise lexicon to improve both intramural and extramural communication of our science.</li>
<li>Cardiovascular Clinical Development Support:</li>
<li>Collaborate internally with clinical and regulatory departments to support the planning, execution, and management of clinical trial activities.</li>
<li>Cardiovascular Medical Communications:</li>
<li>Develop a CV medical communication strategy including Medical Platform statements, lexicon, standard responses, a core scientific education slide library, and competitive intelligence trackers that will serve as the foundation for external scientific exchange and internal training.</li>
<li>Drive engagement with internal and external stakeholders to understand communication needs and serve as an expert resource. This will include the establishment, planning, and execution of Scientific and other Advisory Boards.</li>
<li>Identify external educational needs and create/execute external educational efforts (Symposiums, CME sessions, etc) to address these deficits in support of CV medical affairs strategy.</li>
<li>Cardiovascular Real-World Evidence (RWE) & Health Economics and Outcomes Research (HEOR):</li>
<li>Lead the strategic development and implementation of RWE and HEOR initiatives specific to cardiovascular therapeutics.</li>
<li>Cardiovascular Field Medical:</li>
<li>Identify and build relationships with key external stakeholders including, but not limited to, investigators, healthcare providers, payors, healthcare institutions, professional societies, and advocacy groups.</li>
<li>Responsible for the collection of insights and successful dissemination of innovative clinical information to thought leaders, payers, and other key external stakeholders.</li>
<li>Medical Affairs Operations: (built in collaboration with Musculoskeletal Medical Affairs)</li>
<li>Support the development of departmental budget, forecasting, and long-range planning, and tracking operational expenses.</li>
<li>Prepare and maintain policies and SOPs to ensure compliant dissemination of medical information</li>
<li>Cardiovascular Advocacy & Professional Organizations (in collaboration with Patient Advocacy):</li>
<li>Oversee engagement with professional societies and industry organizations focused on advancing clinical knowledge, infrastructure, and practice enabling the adoption of precision medicine to improve patient outcomes.</li>
<li>Work to infuse the patient perspective and strategic insights from patient advocacy group partners into the business, leveraging existing initiatives - including Patient Councils across core therapeutic areas - and new opportunities to inform and influence strategy from discovery to clinical development to commercialization.</li>
</ul>
<p>Required Education, Experience and Skills:</p>
<ul>
<li>Advanced science degree with 10+ years of related experience within the pharmaceutical industry. Degree in pharmacy or advanced degree in science/medicine (MD, PhD, MD/PhD, DNP, or PharmD)</li>
<li>Background in cardiovascular disease and cardiomyopathy ideal</li>
<li>Self-directed individual with the ability to multi-task effectively and deliver results on-time.</li>
<li>A flexible team player with a no-job-too big or too small attitude, who thrives in a fast-paced and energetic environment.</li>
<li>Strong organizational skills/business planning.</li>
<li>Creative problem-solving skills.</li>
<li>Proven ability to develop and grow productive relationships with external and internal stakeholders in a range of disciplines.</li>
<li>Demonstrated ability to present complex scientific and medical information to a range of audiences.</li>
<li>Ability to critically appraise medical/scientific literature with attention to the strategic needs ensuring alignment with publications plan.</li>
<li>Able to translate corporate strategies and objectives and apply to medical/scientific communications, as appropriate.</li>
<li>Excellent communication skills with an ability to develop collaborative relationships and work effectively with all levels of management.</li>
<li>Excellent presentation skills and experience creating slide deck modules for internal and external communication.</li>
<li>A proven track record of strong writing and reviewing skills that are compliant with legal, requirements, local policies and procedures, including Good Publication Practices</li>
<li>Ability to effectively manage medical communications agencies and/or freelancers.</li>
<li>Able to identify and manage differences through discussion and agreement, as appropriate.</li>
<li>Demonstrates high ethical and professional standards with all business contacts.</li>
<li>Ability to represent the needs of a broad range of stakeholders in development of real-world evidence strategy and tactics.</li>
<li>Experience developing external and internal engagement and education tools.</li>
<li>Demonstrates expert knowledge and proficiency with general office procedures such as commonly used office software (e.g., MS Office-Word, Excel, PowerPoint,).</li>
<li>Strong written communication and project management skills.</li>
<li>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.</li>
<li>Ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner.</li>
<li>Willingness and ability to travel up to 25% of the time.</li>
</ul>
<p>Salary range: $200,000-$280,000, title and salary commensurate with experience</p>
<p>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.</p>
<p>There is no deadline because the employer accepts applications on an ongoing basis.</p>
<p>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.</p>

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