AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

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 Associate Director, Medical Affairs Operations and Capabilities will lead the development and implementation of strategic planning of the Medical Affairs Operations/Capabilities Excellence and refine medical strategies to afford optimized global launch readiness and a robust external engagement program.

This position will be remote-based and will report to the VP of Medical Affairs.

Job Responsibilities

Medical Operations Strategic Planning and Execution:

• Lead the development and implementation of strategic planning tools and frameworks for medical planning preparations execution and accelerated readiness through process and system optimization.

Strategic planning and execution of Material Review Board (MRB):

• Lead MRB process and implementation of Veeva platform to support the review of submitted materials to ensure compliance standards based on AskBio SOPs.

• Lead the implementation of Veeva platform for MRB working in close collaboration with regulatory and medical affairs team members.

Medical Affairs Operations excellence for Publication planning:

• Lead publication process and implementation of review portal working closely with publication managers.

• Provide training and ensure compliance is met based on the publication policy and SOP set by AskBio standards.

System Evolution and Compliance:

• Define business requirements for Medical Operations, Field, and medical systems and corresponding SOPs

• Lead the evolution of these systems to meet business needs and compliance standards.

Medical Insight Generation:

• Design and deliver an enhanced Medical Insight Generation process.

• Drive the framework, tools, and channels of insight collection to enable integration within AskBio, Bayer partners, and therapeutic teams.

Congress planning, Collaboration and Engagement:

• Work closely with Therapeutic area leads and external affairs to plan the congresses to support the scientific messages and external engagement.

• Work collaboratively with External Engagement Medical Directors, Field Medical Liaisons, and Field Directors to develop consistent engagement strategies align with strategic planning and system requirements e.g. Veeva.

• Lead the development and implementation of Medical Affairs Therapeutic Team strategic asset plans.

• Partner closely with internal collaborators and vendors and Medical Affairs teams, and vendors to build, pilot, and scale digital initiatives and capabilities.

Vision and Decision Making:

• Balance long-term vision with short-term delivery.

• Support and Influence decisions to invest, build, and sustain initiatives to catalyze the organization towards its vision.

Digital Systems and Analytics:

• Serve as the single point of contact for Medical Affairs across digital systems and analytics.

• Effectively communicate with key stakeholders and deliver relevant and clear content, training, and information. E.g. Malbec, coupa and Veeva internal and external stakeholders

Project Leadership and Guidance:

• Lead a wide range of advanced projects.

• Provide advice and guidance to less experienced colleagues on project support tactics.

Minimum Requirements

• Bachelor’s degree in life sciences or healthcare related field and 8+ years’ relevant work experience OR Master’s degree in life sciences or healthcare related field and 6+ years’ relevant work experience

• Extensive biotechnology or pharmaceutical industry experience in a medical affairs, clinical, and/or operations role

• Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and with cross-functional teams

• Intrinsically motivated with strong problem-solving skills, allowing analysis, synthesis, and compilation of data from a broad range of disciplines

• Strong interpersonal skills for effective professional communications with internal and external stakeholders

• Excellent presentation and software skills (e.g., Word, Excel, PowerPoint)

• Strong leadership and strategic planning skills

• Strong track record of partnering with cross-functional stakeholders

• Proficiency in digital systems and analytics

• Ability to inspire and drive team performance

• Ability to travel to meetings / conferences up to 25% of the time

Preferred Skills & Abilities

• Prior experience in medical capabilities development in early and late-stage clinical development areas.

• Launch planning experience to support medical affairs operations/capabilities

• Advanced professional degrees including MBA, MSc, PhD or PharmD

AskBio 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 [email protected].

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.