Medical Director, Cardiovascular/Metabolic

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, Germany, 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 Medical Director, Clinical Development (Cardiovascular/Metabolic), reporting to the Senior Vice President, Global Clinical Development, will be the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple molecular entities. Serving as a core member of the Global Program/Project Team led by the Therapeutic Integrated Product Team Leader, this position owns the clinical aspects of the product development strategy, and will be accountable for the design, medical oversight of execution, and reporting of a clinical development program(s) to support internal governance decisions, regulatory submissions, and market access. The ideal candidate will be able to lead a matrixed, cross-functional Clinical Development team to develop and implement a Clinical Development Plan (CDP).

This is a US-based, hybrid schedule position, allowing for a blend of remote work and in-office presence at our Research Triangle Park or Philadelphia headquarters.

Job Responsibilities

• Represent Clinical Development on the Global Program/Project Team

• Develop the Clinical Development Plan (CDP), in line with the Target Product Profile (TPP), for successful global regulatory approvals and market access for one or multiple indications and execute the clinical strategy in partnership with the Therapeutic Sector Leader

• Design and report clinical trials in collaboration with the Therapeutic Integrated Product Team Leader, Biostatistics and other relevant functions

• Lead the creation of clinical components of key study documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Informed Consent Forms, Risk-Based Medical Monitoring Plan, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers with high quality and consistency with IDP and TPP

• Provide medical oversight of trial execution, assure timely initiation of studies, support recruitment and retention activities and reach study timelines/milestones in collaboration with Clinical Operations

• Ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance in collaboration with the Medical Safety Monitor

• Serve as a core member for the program Safety Management Team

• Participate in interactions with external stakeholders (Regulatory Authorities, KOLs, Data Monitoring Committee (DMC), Advisory Boards, Patient Advocacy Groups), internal stakeholders (Therapeutic Sector Leaders, Clinical Operations, Biostatistics, Regulatory Affairs, Project Management, Research, Technology Development, Manufacturing, Translational Medicine, Global Medical Affairs, Marketing and Market Access, Business and Corporate Development), and internal governance committees as a medical expert

• Serve as project leader to strategize and execute a development program under the guidance of the Therapeutic Sector Leader

• Support technical due diligence in Business Development & Licensing (BD&L) activities

• Organize and manage scientific and/or clinical advisory boards alongside Medical Affairs and other relevant functions

Minimum Requirements

• MD or DO with 6 years’ relevant experience in clinical research in cardiovascular or metabolic diseases (experience can be a combination of industry and academic experience)

• Clinical research experience spanning early and late phase drug development, including IND and NDA submission dossiers

• Advanced knowledge in gene therapy or similar biologics and prior training or extensive experience in rare genetic disorders

• Advanced clinical training, knowledge or research experience in a medical/scientific area aligned with AskBio’s focused therapeutic areas (cardiovascular, CNS, neuromuscular, metabolic, genetic disorders)

• Demonstrated leadership and strong communication skills with a documented track record of delivering high quality projects, submissions, trials in a global/matrix environment in pharmaceutical or biotech industry, academia or clinical CRO

• Experience and achievements in non-clinical research and development (research, translational medicine, medical affairs, medical safety, regulatory affairs) in academia or biopharmaceutical industry

• Experience in pediatric cardiovascular conditions, and/or heart failure, with the capability to integrate non-clinical work to innovate clinical development study designs that provide robust clinical evidence to internal decision-makers and regulatory agencies

• Experience with regulatory submissions and interactions with health authorities

• In-depth knowledge of ICH-GCP, clinical trial design, statistics, and regulatory/clinical development process

• Ability to establish strong scientific partnerships with internal and external key stakeholders

• Hands-on experience in organizing and managing scientific/clinical advisory boards

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.