VP, Head of Global Cardiovascular Programs

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.

At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.

We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.
  
  

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
  
  

Position Summary

The VP, Global Medical Head of Cardiovascular, reporting into the SVP, Global Head of Medical Affairs, is a newly created role that will provide strategic and operational leadership to AskBio’s Medical Affairs Cardiovascular team. With a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards, this individual will be responsible for the legally compliant execution of the Medical Affairs functions for development programs and in the future for approved and commercialized products. The VPMA responsibilities will include, but not limited to: Medical Communications and Publications, Patient Advocacy, Investigator-Initiated Trial program, Medical Science Liaisons group, Continuing Medical Education, Health-Economics Outcome Research (HEOR), Medical Advisory Boards and Medical Review of Commercial/Marketing Materials.

The VPMA will set the vision and direction for the team and partner with Therapeutic Sector Leadership, Clinical Development, Regulatory Affairs, and Marketing to develop and operationalize medical strategy for global development programs and commercial products.

The incumbent will be responsible for building and guiding a Medical Affairs function ahead of the organization's first commercial launch. Oversee the therapeutic area and team that works closely across groups within Worldwide R&D (WWRD), with the IPT teams, Clinical Development, Business Development, Bayer Head of New Product Commercialization, Global Value, Access & Strategic Pricing (GVASP), the Regions, and Key Strategic Markets, to provide cardiovascular medical strategy across all company programs and input into research and clinical programs to maximize health outcomes, clinical adoption and patient access. With Ask Bio’s goal of growing the pipeline and accelerating new program identification, this role will be pivotal in providing expertise to help shape cardiovascular programs and progression and support the growth through strategic program and lifecycle management

AskBio’s early development opportunities and leadership in Gene Therapy span across cardiovascular from Pre-clinical to Phase II, and programs in CNS, Neuro muscular, Immunology, and rare diseases providing a breadth of opportunity for this hire to build out the company’s reach and scope in the biopharma industry. AskBio’s goal is to file a minimum of one IND per year starting in 2024 and to progress multiple assets into development by 2025. This role will guide teams to prioritize and shape the development programs to maximize patient outcomes in clinical practice and patient access through robust pre-clinical Medical Strategy and evidence generation plans through the lifecycle. The role also will be a critical member of the Global Medical Affairs leadership team, a strategic partner to the IPT, Commercial, External Affairs HEOR, Market Access, Clinical Development and Chief Medical Office.

Job Responsibilities

• Lead the creation of strategic plan that will differentiate the clinical endpoints and outcomes for clinical trials and real-world evidence generation In the Cardiovascular space that are meaningful for physicians to change clinical practice, maximize patient access and outcomes for all programs informing phase II, Launch and lifecycle management
• Work Closely with IPT, VP Early Asset and Pre-Clinical Medical Strategy for continuity and acceleration of programs and projects
• Help shape development plans beyond regulatory requirements for local unmet needs and standard of care.
• Drive cross functional shaping for programs in AskBio’s portfolio as they advance from early research to commercialization and lifecycle management.
• Lead understanding of clinical practice, unmet need, guidelines, and patient journey in the Cardiovascular therapeutic areas, establishing strong coordinated early Medical Affairs plans.
• Inform and help tier new program assessments, so the most transformational assets are prioritized.
• Inform and help define the target product profile for any new or early-stage assets for transformational impact for patients.
• Lead and execute global scientific engagement strategy and drive excellence in scientific engagement with all key stakeholders
• Develop, initiate, and maintain strong relationships with international scientific leaders and key stakeholders to enhance awareness of AskBio’s asset portfolio
• Organize and manage global expert events (advisory boards, expert panels, symposia) in conjunction with cross functional team members
• Function as an adhoc member in discussions of in-licensing and out-licensing of assets, collaborating closely with the business development team and VP Early Asset and Pre-Clinical Medical Strategy.
• Serve as the Cardiovascular Therapeutic Medical Affairs lead for AskBio internally and externally for all Legal, Regulatory and Compliance approvals
• Drive early medical expert and scientific engagement in key strategic countries.
• Ensure strong Scientific Communications plans are being executed in the different geographical areas prioritizing expected areas of Clinical Trials and commercialization
• Support of R&D, through the drug development process; and evaluation of business development and pipeline opportunities.
• Lead and execute global scientific engagement strategy and drive excellence in scientific engagement with all key stakeholders
• Ensure deep local and stakeholder insights to inform shaping of pipeline assets.
• Partner with medical training team to develop and deliver high quality scientific and skill-based training to medical team across regions
• Liaise with global and regional medical affairs to ensure medical insights from all key markets are integrated into and inform product development
• Represent medical affairs at appropriate leadership and development forums
• Lead and coach members of the Cardiovascular extended Medical Team.
• As a member of the Global Medical Affairs Leadership team, contribute to leadership of the overall and broader medical and company roadmap
• Partner with Alliance companies and Bayer as appropriate
• This role can be based in the US (United States) or EU (Europe)
  
  

Minimum Requirements

• Minimum 15 years’ experience working in the biopharmaceutical industry in Global Medical Affairs and/or Development with increasing responsibilities, complexity, and accountabilities. US, Global and major EU experience is required.
• MD is required.
• Prior experience driving medical transformation within your organization in a cross-functional capacity
• Successful product launch experience
• Technical skills covering end to end lifecycle management, launch planning and execution, and disease area shaping
• Experience creating high quality integrated evidence and scientific external engagement packages including creating processes, systems and compliance needs
• Track record working within large, complex organizations influencing R&D and partnering with and understanding the global landscape
• Cross-functional senior leadership experience acting as an evangelist for transformation and innovation
• Proficient in presenting new ideas, initiatives, and business rationale to Board and C-level leaders to gain alignment and update on progress
• Track record for attracting and developing talent and optimizing team performance in direct and matrixed leadership roles
• Strong written and verbal communication skills
• Excellent interpersonal and leadership skills
• Demonstrated reputation as a well-respected, dynamic team leader, and player-coach
• Ability to deliver on company global program goals and objectives as they pertain to medical affairs
• Ability to affect positive organizational change at the company and team levels
  
  

Preferred Skills & Abilities

• Experience with Gene Therapy, rare disease, immunology, neuroscience, and/or cardiovascular therapeutic areas is preferred.
  
  

Preferred Competencies:

SETTING STRATEGY

• The ability to create and articulate an inspiring vision for the organization, not only for the areas they are directly responsible for, but the enterprise as a whole.
• 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.
  
  

EXECUTING FOR RESULTS

• The ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results.
• Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• A leader who is 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.
  
  

LEADING TEAMS

• The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers.
• A leader who is self-reflective and aware of their own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.
  
  

RELATIONSHIPS AND INFLUENCE

• 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.
• Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others to the greater purpose for the organization as a whole
  
  

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.