Generate Biomedicines

Clinical Research

• Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
• Act as a key scientific contributor to late-stage protocols and regulatory submissions
• Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader
• Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
• Interpret clinical data in collaboration with cross-functional colleagues and external partners
• Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans
• Participate in data review and medical monitoring activities
• Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
• Support development and execution of publication plans, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)

Director, Clinical Scientist – Respiratory Indications

Director

• Lead statistical programming activities for multiple clinical trials within a program or an indication/disease area, or development program.
• Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
• Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements.
• Coordinate activities of internal/external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s).
• Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries.
• Manage the statistical computing environment, including folder structure and access control.
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams.
• Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
• Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications.
• Collaborate with cross-functional departments - Clinical operations, Translational science, Clinical science, Pharmacovigilance to gather the requirements and provide necessary outputs and analyses in SAS and Spotfire dashboards as per the requirement.
• Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming group.
• Must be able to program defensively, check results, and consistently produce accurate output.
• Responsible for allocating resources within a program and ensuring resource sharing between programs.
• Recruit, mentor, and develop statistical programmers and interns.
• Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan).
• Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training.
• Represent statistical programming at indication or program level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC).
• Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives.
• Adhere to FDA regulations regarding training records, guidelines, and SOPs.
• Adhere to company SOPs/WIs and department guidelines.

Associate Director, Statistical Programming

Vice President

• Leads a high performing Respiratory Product Strategy Team (RPST) comprised of cross-functional leaders accountable for setting the strategy for the late stage respiratory programs
• Direct management and development of medical monitors and clinical scientists
• Develops high quality, ambitious development plans for asthma and COPD programs, aligned with late-stage and corporate objectives and compliant with all relevant regulations
• Recruits, mentors and manages late-state clinicians and scientists
• Collaborates with Head of Safety and PV to define risk-benefit profiles
• Collaborates with Clinical operations and CRO to deliver study to timelines and budget
• Oversees protocol development and clinical/scientific content for regulatory submissions and interactions
• Provides medical leadership and awareness of evolving external landscape for late-stage clinical trials in respiratory diseases (asthma, COPD)
• Drives development and refinement of Target Product Profiles (TPPs), Target Product Claims, and clinical development strategies
• Oversee protocol development, study design, medical review of data, and safety monitoring
• Serve as the primary medical contact for clinical sites, investigators, and regulatory bodies
• Guide interactions with external stakeholders including KOLs, advisory boards, and CROs
• Represent Generate externally at scientific, medical, and regulatory meetings

Vice President, Global Respiratory Products Leader – MD or PhD

• Develop and maintain standardized global clinical site budget templates and negotiation playbooks
• Lead global Phase 1–3 investigator site budget and contract negotiations within approved parameters
• Ensure compliance with regulatory requirements and fair market value standards
• Partner with CROs to oversee global site budget processes and drive consistency across programs
• Proactively identify budget risks, escalate issues, and implement mitigation strategies to protect clinical timelines
• Oversee contract and budget tracking systems, reporting metrics, and dashboard updates
• Establish scalable tools and processes to improve efficiency and reduce administrative burden
• Provide investigator grant budget forecasts and strategic input to Clinical Operations and Finance
• Represent the function in cross-functional governance discussions and strategic planning initiatives
• Liaise with legal department to support efficient clinical site contracts review, escalation, and approval parameters
• Support contract signature and storage workstreams, and various ad hoc clinical and vendor contracts workstreams as required.

Director, Clinical Scientist – Respiratory Indications

Associate Director, Statistical Programming

Vice President, Global Respiratory Products Leader – MD or PhD

Associate Director, Clinical Site Budgets, Contracts