AskBio Inc.

• Responsible for development and delivery of Medical Affairs plan and strategies for Neuromuscular programs • Lead the Senior Medical Affairs leader on Neuromuscular Integrated Product Team (IPT) • Responsibilities include Medical Communications, Patient Advocacy, Field medical strategy, Continuing Medical Education, Health-Economics Outcomes Research (HEOR), Integrated evidence generation • Implement KOL engagement plan in collaboration with clinical operations and clinical development • Collaborate with clinical study teams for recruitment and retention of clinical studies • Execute Medical Affairs activities including key opinion leader engagement, congress planning, publication planning • Establish relationships with thought leaders and advocacy partners • Develop KOL engagement plan, congress strategy, publication plans, and oversee publications • Lead medical educational initiatives in support of defined educational strategies • Generate strategy around patient advocacy and manage budgets and timelines for Neuromuscular medical affairs initiatives

• Be a functional leader in the medical team with matrixed responsibility to IPT leadership; serve as co-leader of the IPT branding sub-team • Partner with Pipeline Commercial, Clinical Development, Clinical Operations, Corporate Communications, R&D, and other functions to develop and implement global Medical Affairs strategies for the Neuromuscular programs while maintaining the highest level of industry compliance, patient centricity and scientific standards • Collaborate with clinical study teams to enable recruitment and retention of clinical studies • Execute and support Medical Affairs activities including key opinion leader engagement, congress planning, advisory boards, publication planning, generation of standard response letters, post marketing data generation and HEOR analysis • Establish relationships and facilitate interactions with thought leaders and advocacy partners (professional and patient organizations) including scientific collaborations, speaker training, advisory boards, and regional/national/international conferences • Develop KOL engagement plan in collaboration with clinical operations and clinical development (incl. KOL mapping based on the needs of the early development program). • Develop congress strategy, including tactical execution about strategic planning of KOL meetings, impact of sessions, competitive intelligence and collection of insights feeding into clinical development program and generation of post-congress debrief reports. • Develop publication plans by conducting data gap analysis to inform publication strategy and publication mapping/planning and provide oversight of all publications including posters, abstracts, and manuscripts at the global level to ensure appropriate dissemination of scientific messages • Partner with internal and external stakeholders to review and edit publications and external communications to ensure content is scientifically accurate and of high quality • Lead the development and execution of medical educational initiatives in support of defined educational strategies • Develop Scientific platform to inform the development of publication plan, communication plan, proactive and reactive slide decks for KOL and advocacy engagements • Lead the medical review process for the Neuromuscular therapeutic area • Lead and execute global scientific engagement strategy and drive excellence in scientific engagement with all key stakeholders • Serve as scientific/clinical knowledge expert for Neuromuscular therapeutic area(s) and disease states to internal and external stakeholders • In collaboration with the External Affairs Team, support external initiatives in alignment with program and product strategies. • Generate a compelling strategy around not only patient advocacy but also professional advocacy • Develop and manage budgets and timelines for all Neuromuscular medical affairs initiatives as described in the Medical Affairs plan and in alignment with IPT’s overarching program strategy • Develop, execute and/or support Therapeutic Area Scientific/Clinical Advisory Board meetings

• Oversee monthly, quarterly, and annual close processes, ensuring timely and accurate financial reporting • Maintain compliance with internal policies, US GAAP / IFRS, and statutory requirements in all reporting activities • Prepare and review journal entries, account reconciliations, variance analysis and support preparation of financial statements for internal and external stakeholders • Manage the consolidation of multiple legal entities, including foreign subsidiaries; ensuring proper translation, elimination, and consolidation entries are recorded accurately • Support income tax compliance process in partnership with external tax advisors • Maintain and enhance internal controls over financial reporting, including documentation and testing of accounting policies, procedures, and control activities • Partner with external auditors to support audit requirements and remediation efforts • Manage assigned general ledger activities, including accruals, prepaids, intercompany, and complex transactions • Prepare supporting schedules and analysis for complex areas such as capitalization, compensation, or provisions and provide clear, concise summaries to management when presenting findings • Assist with balance sheet reviews and provide clear explanations for fluctuations • Provide guidance on technical accounting matters and research complex issues • Identify opportunities to streamline accounting processes and enhance efficiency through automation, standardization, and documentation updates • Support ERP system implementations, upgrades, and optimization initiatives • Research accounting issues and support the application of relevant standards • Assist with various other projects/ department tasks as needed during the growth and evolution of the Company

• Develop and implement an external engagement strategy for our PD and MSA programs aligned to internal business needs and external community needs • Manage patient advocacy and external engagement to support AskBio’s development and commercial strategies in Parkinson’s Disease (PD) and Multiple System Atrophy (MSA) • Identify, develop, and cultivate trust-based relationships with patient advocacy and key patient/caregiver organizations consistent with the phase of development of AskBio clinical programs in CNS • Be responsible for the development and execution of the PD/MSA medical affairs patient advocacy/external engagement plan and ensure its alignment with overall PD/MSA program goals and key deliverables • Participate in and support patient organization events, workshops, and conferences to elevate gene therapy awareness and champion patient community engagement, as directed • Participate as an active member of cross-functional study teams that are responsible for ensuring on-time recruitment and retention of participants for clinical studies • Create and oversee quarterly community newsletter (AAVengers) for the community • Communicate progress, metrics and milestone status for PD/MSA to leadership, R&D partners and others • Engage with patient advocacy groups, foundations, and individual patients to understand their point of view and needs as it relates to patient-focused drug development • Establish and maintain strong relationships with key collaborators in the patient community • Collaborate with cross-functional teams to ensure patient perspective is internally understood and incorporated into company culture and patient needs are considered at all stages of product development • Collaborate with Corporate communications and external agencies to develop patient/advocate awareness of AskBio science and clinical programs • Manage standing patient council meetings and recruit and organize Patient advisory boards, focus groups, meetings as needed, in support of clinical programs • Perform other activities as assigned by the VP Medical Affairs and senior management • Work to cultivate a culture of appreciation for Patients as Partners within Askbio • Collaborate with Integrated Product Team, Clinical Development, Medical Affairs, Regulatory, Corporate Communications, Human Resources, Legal, Compliance and Partner companies to ensure that core values and corporate brand are represented in internal and external initiatives

• Develop and implement an external engagement strategy • Ensure the development and execution of the medical affairs patient advocacy/external engagement plan for Europe • Partner with patient organizations across Europe • Participate in patient organization events and conferences • Implement a detailed framework to ensure EU patient experience is incorporated into all critical business decisions • Engage with patient advocacy groups, foundations, and individual patients • Establish and maintain strong relationships with key collaborators in the patient community • Collaborate with cross-functional teams • Recruit and organize Patient advisory boards and focus groups

• Lead the global strategic clinical development initiatives for AskBio’s GDNF IPT, fostering cross-functional alignment via open and collaborative discussions • Lead, manage, and mentor a team of clinical development physicians • Contribute to budget planning and budget management related to clinical development activities aligned with the IPT goals • Provide clinical development input and maintain alignment with the CNS Drug Delivery IPT and GDNF IPT development plans • Contribute to the development and execution of the clinical strategy across GDNF and other CNS programs • Proactively work to identify clinical risks and implement risk mitigation strategies for complex gene therapy studies • Partner with cross-functional colleagues (including Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory, Commercial, Nonclinical, Drug Delivery and CMC) to design, execute and report clinical trials • Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Study Protocols (CSPs), Investigator’s Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), and other key regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs • Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance.

• Report to the head of Global Clinical Development • Be a core member of the GDNF Integrated Product Team (IPT) • Develop and implement the IPT’s clinical development strategy for clinical programs spanning all stages of product development • Work cross-functionally with groups including Program Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, Nonclinical, Drug Delivery and CMC • Establish and oversee global clinical development strategies in alignment with the company’s mission and values • Build and manage a team of medical directors and provide leadership as co-chair of the IPT’s Clinical Sub-team (CST) • Manage the creation and maintenance of critical study documents assigned to Clinical Development • Partner with Pharmacovigilance and Safety colleagues to provide continuous evaluation of drug safety profile

• Support innovative, comprehensive regulatory CMC strategies and associated timelines for assigned projects to ensure timely global registration of Company’s product candidates in gene therapy • Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW • Provide general operational support to RA CMC team across all programs, including submission management, regulatory project management, and Veeva technical support • Prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections • Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals • Support the development of regulatory processes and standards • Ensure operational alignment and on-time completion of all registration-directed activities through close collaboration with Project Management colleagues and senior management • Partner with Quality Assurance colleagues to ensure regulatory compliance with applicable local and international laws and regulations, as well as industry standards.

• Manage the regulatory CMC strategy and coordinate regulatory activities for all assigned projects • Ensure appropriate development and timely registration of gene therapy product candidates • Drive the preparation and submission of high‑quality CMC sections of regulatory filings • Collaborate closely with CMC, Quality, and external partners • Support innovative regulatory CMC strategies and timelines

Opportunity for Secondment to AskBio We’re pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. If you’re interested in exploring this opportunity, we encourage you to: - Speak with your direct manager to discuss your interest and alignment with your development goals. - Apply directly using the link provided in the posting. We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership. 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 Director, Biostatistics, provides technical leadership and operational oversight for the development of clinical strategies, the design, implementation and reporting of non-clinical, CMC, and clinical development programs and associated studies and clinical trials. He/she participates in close collaboration with the cross functional teams responsible for studies across all phases of drug development. He/she provides guidance and management to statisticians to ensure high quality and timely deliverables. He/she also supports regulatory interactions and serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally. This role reports to VP, Biostatistics, Clinical Development. Job Responsibilities - Responsible for all deliverables related to statistical content. Provides guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables. - Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact. - Oversees the biostatistics function in CRO’s; manages scope of work and relationships with other external statistician consultants as needed. - Manages resources, sets priorities, and ensures consistency and adherence to standards. - Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment. - Responsible for SAP, data analysis and reporting (CSR). Supports DMC charter and meeting preparation - Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities. - Supports regulatory submission and interaction, i.e, and IND/BLA filings and supports potential partnering requests. - Becomes an integral member of cross-functional project teams, provides statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentations. - Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally. - Contributes to creation/maintenance of, and provides training on statistical topics, and departmental SOPs and general standardization efforts. - Maintains currency of new developments in statistics, drug development, and regulatory guidance. - Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities as needed. - Assists with the Business Development activities at key conferences and industry meetings. - Supports scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion Leaders. - Presents at industry conferences representing AskBio - Participates in vendor evaluation, selection, and management. Minimum Requirements - Ph.D. or M.S. in Statistics or related field. - Have 10+ years pharmaceutical experience in a pharmaceutical R&D environment. - Knowledge of Heart Failure and Cardiovascular programs - Previous experience in the preparation and submission of New Drug Applications to regulatory agencies. - Strong knowledge of design of experiments, clinical trial design concepts, or CMC statistics, drug regulation, and experience in the management of the statistical function. Experience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy preferred. - Extensive experience with SAS and/or R - Excellent communication skills - Experience in CRO selection, contracting and management. - Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company 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 talent@askbio.com.