Asklepios BioPharmaceutical, Inc. (AskBio) logo

Asklepios BioPharmaceutical, Inc. (AskBio)

Remote Jobs

Pioneering science to create transformative molecular medicines.

16 open rolesTeam 501,1000Since 2001H1B No SponsorLatest: May 18, 2026, 12:00 AM UTCCompany SiteLinkedIn
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16 Jobs

Asklepios BioPharmaceutical, Inc. (AskBio) logo

Associate Director, Patient Engagement

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Director16 days ago
Full TimeRemoteSeniorTeam 501-1,000Since 2001H1B No Sponsor

• 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

United States
Asklepios BioPharmaceutical, Inc. (AskBio) logo

Associate Director – Patient Engagement

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Director16 days ago
Full TimeRemoteSeniorTeam 501-1,000Since 2001H1B No Sponsor

• 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

Germany
Asklepios BioPharmaceutical, Inc. (AskBio) logo

VP, GDNF Clinical Development

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Vice President25 days ago
Full TimeRemoteLeadTeam 501-1,000Since 2001H1B No Sponsor

• 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.

North Carolina
Asklepios BioPharmaceutical, Inc. (AskBio) logo

VP, GDNF Clinical Development

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Vice President26 days ago
Full TimeRemoteLeadTeam 501-1,000Since 2001H1B No Sponsor

• 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

North Carolina
Asklepios BioPharmaceutical, Inc. (AskBio) logo

Associate Director, Regulatory Affairs, CMC

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Compliance56 days ago
Full TimeRemoteSeniorTeam 501-1,000Since 2001H1B No Sponsor

• 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.

United States
Job Closed
Asklepios BioPharmaceutical, Inc. (AskBio) logo

Associate Director, Regulatory Affairs, CMC

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Compliance70 days ago
Full TimeRemoteSeniorTeam 501-1,000Since 2001H1B No Sponsor

• 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

United States
Job Closed
Asklepios BioPharmaceutical, Inc. (AskBio) logo

Director Biostatistics, Clinical Operations

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

OtherRemoteTeam 501-1,000Since 2001H1B No Sponsor

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.

United States + 1 moreAll locations: United States | United Kingdom
Asklepios BioPharmaceutical, Inc. (AskBio) logo

AD Medical Affairs Operations and Capabilities

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

OtherRemoteTeam 501-1,000Since 2001H1B No Sponsor

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 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 talent@askbio.com.

United States
Job Closed
Asklepios BioPharmaceutical, Inc. (AskBio) logo

Medical Affairs Operations Specialist

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

OtherRemoteTeam 501-1,000Since 2001H1B No Sponsor

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 Medical Affairs Operations Specialist plays a critical role in enabling the effective and compliant execution of Medical Affairs activities. This position manages contract, invoice, and purchase order processes; coordinates operational logistics for congresses and Medical Affairs initiatives; supports the Medical Review Board (MRB) process; and maintains structured documentation and tracking systems. The Specialist enhances team effectiveness through strong organizational skills, proactive problem‑solving, and collaboration with key stakeholders across Legal, Finance, Procurement, and other internal functions. This role is essential to ensuring Medical Affairs programs run efficiently, compliantly, and with operational excellence. Job Responsibilities - Manages and tracks Medical Affairs contracts, invoices, and purchase orders to ensure accurate processing, timely payments, and compliant documentation - Provides operational support for Medical Affairs initiatives, including congress and conference planning, logistics coordination, vendor communication, and tracking conference‑related deliverables - Supports the Medical Review Board (MRB) process as needed by preparing materials, coordinating schedules, and maintaining organized documentation - Enhances team efficiency by maintaining spreadsheets and shared files, coordinating meetings, and facilitating cross‑functional communication with Legal, Finance, Procurement, and other internal partners - Supports other projects in Medical Affairs as needed Minimum Requirements - Bachelor’s degree in life sciences, healthcare, business administration, or a related field with 2+ years’ related industry experience OR High School Diploma and 6+ years’ related industry experience - Related work experience in Medical Affairs operations, clinical operations, project coordination, vendor management, finance/PO processing, or related regulated industry work - Strong organizational and prioritization skills and attention to detail - Proficiency in MS Office Suite and document management systems - Excellent communication and interpersonal skills (written and oral) - Ability to manage multiple priorities in a fast-paced environment - Strong problem-solving and analytical skills - Commitment to compliance and quality standards Preferred Education, Experience and Skills - Master’s degree in life sciences, healthcare, business administration or a related field - Project management experience and/or certification - Experience managing contracts, purchase orders, invoices, or budget tracking within structured processes 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.

United States
Job Closed
Asklepios BioPharmaceutical, Inc. (AskBio) logo

Medical Director, GDNF

Asklepios BioPharmaceutical, Inc. (AskBio)

Pioneering science to create transformative molecular medicines.

Medical Director86 days ago
OtherRemoteTeam 501-1,000Since 2001H1B No Sponsor

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 - Lead and execute the clinical development strategy for gene therapy programs across early- and late-stage development (Phase 1–3) - Provide medical and scientific input into clinical trial design, protocol development, dose escalation strategies, and endpoint selection, particularly for CNS and movement disorders - Oversee all clinical trials from initiation through completion, ensuring data integrity, patient safety, and regulatory compliance - Collaborate with internal cross-functional teams and external partners, including CROs, investigators, vendors, and regulatory agencies - Conduct clinical risk assessments and implement appropriate mitigation strategies, including safety monitoring and benefit–risk evaluations - Contribute to regulatory interactions, including briefing documents, investigator brochures, and responses to health authority questions - Present clinical data and development updates to senior management, governance committees, and external stakeholders - Supervise, mentor, and support clinical team members and contribute to a high-performing development organization - Establish and maintain oversight of clinical monitoring activities across studies in a highly regulated environment, ensuring compliance with ICH-GCP, regulatory requirements, and internal quality standards - Author and review key clinical and regulatory documents, including clinical protocols, investigator brochures, clinical study reports, and regulatory submissions, ensuring scientific rigor, clarity, and compliance with applicable regulatory requirements and internal standards. Collaborate cross-functionally with clinical operations, regulatory affairs, biostatistics, and safety to ensure documents accurately reflect study conduct, data interpretation, and overall clinical strategy - Drive innovation in clinical trial execution, particularly in rare disease, CNS, and gene therapy settings Minimum Requirements - MD from an accredited U.S. medical school or equivalent international medical degree with 6+ years’ relevant work experience - Completion of clinical training with demonstrated clinical experience; board certification or eligibility in Neurology or a closely related specialty - Minimum of 3 years of industry experience or related experience in clinical research or clinical development within the pharmaceutical, biotechnology, medical device, CRO/CDMO, or closely related academic or translational research setting - Direct experience contributing to the design and execution of clinical trials, including protocol development and clinical data review - Demonstrated working knowledge of Good Clinical Practice (GCP), including clinical monitoring, safety oversight, and data quality standards - Experience supporting inspection readiness activities, including preparation for or participation in FDA or other health authority inspections, audits, or internal quality reviews - Ability to independently perform the core duties of a Medical Director in a regulated drug development environment - Ability to provide medical oversight for FDA inspection readiness, including review of key trial documentation, monitoring outputs, and safety narratives - Experience reviewing and interpreting monitoring reports, audit findings, protocol deviations, and CAPAs - Strategic oversight of risk-based monitoring and trial quality management approaches - Understanding of gene therapy–specific safety risks, including delayed adverse events and durability considerations requiring extended follow-up - Strong analytical and problem-solving skills applied to clinical, safety, and compliance issues - Excellent written and verbal communication skills, including interaction with senior leadership and regulatory agencies Preferred Education, Experience and Skills - Prior experience in CNS, neurology, or movement disorders clinical development - Experience with gene therapy, cell therapy, or other advanced therapeutic modalities - Experience supporting or leading early Phase development programs including Phase 1 and 2 and/or Phase 3 trials, including registrational strategies - Experience with long-term follow-up (LTFU) studies, including post-treatment safety monitoring required for gene therapy products - Direct experience partnering with CROs and CRAs on monitoring strategy, risk-based monitoring, and vendor oversight - Experience working in rare disease or small patient population studies 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.

United States

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