The Medical Director will collaborate across Medical Affairs, Clinical Development, Commercial, HEOR, Medical Excellence, Field Medical, Medical Information, Scientific Communications, and Publications to ensure alignment, generate impactful scientific evidence, and strengthen external partnerships within the respiratory community.

Key Responsibilities

• Develop and lead the global Medical Affairs strategy for the respiratory indication, ensuring alignment with overall corporate objectives.
• Translate strategic priorities into comprehensive Medical Affairs plans that support key development and launch milestones.
• Provide medical leadership and strategic input to cross-functional teams including Clinical Development, Clinical Operations, HEOR, Commercial, and other key stakeholders.
• Build and maintain strong relationships with external experts, key opinion leaders (KOLs), and the broader respiratory medical community.
• Lead the medical data generation strategy by identifying evidence gaps and developing integrated plans to support scientific and clinical objectives.
• Review scientific publications and develop medical backgrounders, FAQs, standard response documents, and internal training materials.
• Develop and execute a comprehensive thought leader engagement strategy.
• Partner with Medical Strategy, Regional teams, and Finance to develop and manage annual Medical Affairs budgets.
• Foster strong collaboration across Global Medical Affairs, Regional Medical teams, Commercial, Clinical Development, and other functional groups to ensure a unified approach.
• Identify opportunities to incorporate innovative ideas, best practices, and operational improvements into Medical Affairs strategies and activities.
• Ensure all Medical Affairs activities are conducted in compliance with company policies and applicable regulations.

Qualifications

• Previous Medical Affairs experience in pulmonology/respiratory medicine is required.
• Strong understanding of Medical Affairs strategy, planning, and execution, with launch experience preferred.
• Demonstrated success developing innovative Medical Affairs strategies and programs.
• Proven ability to represent Medical Affairs as a strategic leader on cross-functional teams.
• Experience working effectively within a complex global matrix organization.
• Previous leadership experience with the ability to lead through influence across cross-functional teams.
• Global experience, or experience working across multiple regions including the United States, is preferred.
• Strong collaboration and stakeholder management skills across multiple functions.
• Proven track record of driving operational excellence, improving processes, and establishing planning standards.
• Strategic thinker with the ability to connect scientific, clinical, and commercial priorities.
• Demonstrated success leading organizational change and driving continuous improvement.
• Excellent written and verbal communication skills.
• Strong problem-solving abilities with a creative, solutions-oriented mindset.
• Exceptional organizational skills and attention to detail.
• Willingness to travel domestically and internationally as needed (up to 25% travel).

 Education

• MD degree minimum 6 years medical affairs experience

As the medical lead for assigned programs, you will provide expert oversight of medical monitoring, clinical strategy, data interpretation, regulatory interactions, and scientific communications. Working collaboratively across Research, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Commercial, and other key stakeholders, you will play a critical role in advancing innovative therapies for patients with neurologic diseases.

Key Responsibilities

• Lead the strategic planning, design, and execution of global clinical development programs across all phases of development (Phase I–III), ensuring the successful delivery of high-quality clinical studies.
• Serve as the therapeutic area lead for the Neurology Gene Therapy Clinical Development team, partnering closely with leaders across Clinical Operations, Toxicology, Regulatory Affairs, Commercial, Pharmacovigilance, Clinical Quality, and Biostatistics.
• Provide medical oversight and monitoring for clinical trials, ensuring patient safety, protocol compliance, data integrity, and overall study quality.
• Lead clinical operational strategy related to site selection, enrollment, feasibility assessments, and study execution, serving as the primary medical escalation point for issues that may impact study quality or timelines.
• Collaborate with Clinical Operations on medical monitoring, coding, safety review, and data cleaning activities.
• Interpret clinical trial data and ensure the scientific accuracy and medical integrity of clinical study reports, presentations, and communications.
• Author or oversee the preparation of clinical sections for regulatory submissions, including INDs, NDAs, BLAs, briefing books, and other regulatory documents.
• Represent the company during interactions with regulatory agencies, including FDA meetings, Advisory Committee presentations, and other health authority engagements.
• Develop or oversee safety management documents, including Data Monitoring Committee (DMC) charters, safety management plans, investigator communications, and other study-specific documents.
• Prepare or review Serious Adverse Event (SAE) reports and Investigator Alert Letters in collaboration with Clinical Operations, as needed.
• Build and maintain strong relationships with CROs, investigators, clinical consultants, key opinion leaders (KOLs), investigational sites, and other external partners supporting clinical development.
• Analyze, interpret, and communicate clinical data through presentations, publications, scientific meetings, and advisory boards.
• Organize and lead Scientific Advisory Board meetings and Data Monitoring Committee meetings.
• Maintain current expertise in neurology, gene therapy, and emerging scientific advances through ongoing literature review and participation in scientific and medical conferences.
• Develop and manage clinical development budgets while providing regular updates on program progress, timelines, and key risks.
• Serve as an active member of the Gene Therapy Leadership Team, contributing to the strategic direction of the business and identifying future opportunities and potential challenges.
• Support business development initiatives, product evaluations, licensing opportunities, and due diligence activities.
• Provide medical and clinical expertise to internal stakeholders, including Research & Development, Commercial, Marketing, Manufacturing, Market Access, Patient Services, Regulatory Affairs, and Legal, as well as external stakeholders such as healthcare professionals, advocacy groups, and data monitoring committees.
• Coach, mentor, and develop direct reports while fostering a collaborative, high-performing clinical development organization.

Qualifications

• MD (or foreign equivalent) with clinical training and experience in Neurology required.
• PhD in a related scientific discipline preferred.
• Minimum of 10 years of clinical development experience within the pharmaceutical or biotechnology industry, including global clinical programs across Phases I–III.
• Minimum of 5 years of leadership experience managing clinical development teams.
• Clinical residency training in Neurology required.
• Pediatric neurology experience preferred.
• Gene therapy experience preferred.
• Demonstrated expertise in medical monitoring, clinical trial design, regulatory strategy, and interpretation of clinical data.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and global clinical development requirements.
• Proven ability to lead cross-functional teams, influence executive stakeholders, and successfully manage complex clinical development programs.
• Excellent scientific communication, presentation, and leadership skills.
• Willingness to travel domestically and internationally up to 20%.

We are seeking an experienced Senior Clinical Programmer to support clinical development programs by delivering high-quality programming solutions for medical monitoring, data management, and statistical programming activities. The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to develop efficient, compliant, and scalable programming solutions that support ongoing clinical trials.

Key Responsibilities

• Provide programming support for medical monitoring, data management, and statistical programming activities across clinical studies.
• Develop specifications for SDTM dataset creation in accordance with CDISC SDTM Implementation Guide (SDTM IG).
• Program, validate, and maintain CDISC-compliant SDTM datasets.
• Create and maintain annotated CRFs (aCRFs) aligned with SDTM specifications.
• Generate outputs and listings to support medical monitoring, data review, statistical endpoint monitoring, and data management activities.
• Develop, enhance, and maintain SAS macros, R functions, and other reusable programming utilities.
• Design, develop, test, and implement programming solutions to address complex business and study requirements.
• Ensure programming deliverables meet quality standards, timelines, and regulatory expectations.
• Collaborate effectively with cross-functional teams including Biostatistics, Data Management, Clinical Operations, and Medical Monitoring.
• Manage multiple projects simultaneously while delivering high-quality work within established timelines.

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline (or equivalent experience).
• Experience programming in the pharmaceutical, biotechnology, or related regulated industry preferred.
• Advanced programming proficiency in SAS, R, and SQL.
• Strong working knowledge of CDISC standards, including SDTM and annotated CRFs.
• Experience with JReview is highly preferred.
• Experience with Shiny, Pharmaverse, and R Markdown is preferred.
• Familiarity with programming languages such as Python, VBA, or C++ is a plus.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Strong organizational skills with the ability to prioritize multiple assignments and meet deadlines.

Preferred Experience

• Experience supporting medical review or clinical data review activities.
• Experience developing reusable programming utilities and automation tools.
• Familiarity with regulatory submission standards and clinical trial data workflows.
• Experience working in a fast-paced clinical development environment.

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

Job Overview

We are seeking a highly skilled and motivated Biostatistician to lead our biometrics function across multiple studies in one of the late-phase programs for cardiovascular drug development. As the AD Biostatistician, you will be the study lead, representing biometrics in cross functional team meetings. You will be responsible for discussing and shaping the clinical development plan, study design, endpoint selection, statistical analysis plan, and regulatory submission and publication strategy to support pursuant of precision medicine. This role involves overseeing CROs and collaborating with cross-functional teams to deliver high-quality analysis outputs and interpret results.

Essential Duties And Responsibilities

• Collaborate with clinical, regulatory, medical affairs, and other teams to ensure cohesive and integrated project strategies.
• Contribute to clinical protocol development and study reports, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.
• Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings.
• Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
• Provide statistical input to data monitoring committee (DMC) charters.
• Oversee the CROs or internal teams to deliver high-quality and timely analysis outputs and interpret the results.
• Manage statistical activities in support of NDA/MAA or other regulatory submissions.
• Address statistical questions/comments from FDA and other regulatory agencies.
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.
• Contribute or lead standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.
• Provide guidance and oversight to ensure compliance with regulatory standards and best practices.
• Mentor junior statisticians.

Qualifications And Preferred Skills

• PhD in Statistics, Biostatistics, or a related scientific field with 7+ years of experience, or MS with 10+ years of experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
• Expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
• Knowledgeable of machine learning approaches for classification and predictive modeling.
• Excellent communication and presentation skills, with the ability to convey complex statistical concepts to non-statisticians.
• Strong knowledge and hands-on experience of statistical software (SAS, R or Python) and proficiency in implementation of advanced analytical methods especially for data visualization.
• Experience in managing CROs and collaborating with cross-functional teams.
• Experience with NDAs, and MAA’s is highly desired.
• Experience with cardiovascular drug development and digital health data or real-world data is preferred.
• Demonstrated ability to work independently and as part of a team in a fast-paced, dynamic environment.

• Independently update, revise, and finalize regulatory documents, including protocol and IB
• Support preparation and maintenance of protocol amendments, submission support documents, and related deliverables within Common Technical Document (CTD Modules 2–5) across the submission lifecycle (responses, amendments, briefing packages)
• Ensure scientific accuracy, clarity, consistency, and compliance across all regulatory documents
• Collaborate with internal teams and contract writers to ensure timely delivery aligned with regulatory and quality standards
• Support intermittent workload demands (~10–15 hours/week during active project periods)

• Regulatory medical writing experience supporting IND, CTA, NDA, and/or BLA submissions
• Strong familiarity with Common Technical Document (CTD) structure and regulatory submission lifecycle (e.g., responses, amendments, briefing packages)
• Ability to work independently with minimal oversight in a fast-paced, cross-functional environment
• Strong attention to detail with demonstrated ability to ensure scientific and regulatory quality standards
• Proven collaboration experience with regulatory, clinical, and medical writing teams

We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages.

Key Responsibilities

• Lead statistical programming activities across global studies
• Serve as primary programming lead in collaboration with Biostatistics
• Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards
• Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions
• Validate program outputs and ensure accuracy, quality, and regulatory compliance
• Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively
• Manage timelines, delivery packages, and milestone commitments
  Contribute to continuous improvement of programming processes and standards

Core Requirements

• Strong expertise in CDISC standards, including ADaM and SDTM
• Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables
• Working experience in LSAF environment
• Experience validating CRO programming deliverables
• Ability to operate with increased performance accountability and ownership
• Strong CRO-facing communication and collaboration skills
• Proven ability to manage multiple global studies simultaneously

Additional Requirements 

• Practical experience with multiple imputation (MI), particularly under Missing at Random (MAR) assumptions
• Familiarity with the estimands framework (ICH E9 R1) and managing intercurrent events (ICEs) within ADaM domains using various strategies

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field
• 5+ years of SAS programming experience within pharmaceutical/biotech
• Strong understanding of statistical methods used in clinical trial analysis
• Knowledge of Good Programming Practices and GCP
• Preferred: Experience with R programming

The Senior Real-World Analyst (RWA) will be responsible for conducting analyses for Real-World Evidence (RWE) studies utilizing administrative claims, electronic medical records (EMR), and registry data. The successful candidate will possess a deep understanding about the use of Real-World Data (RWD), exceptional programming and analytical skills and a proven track record in delivering high-quality RWE analytic projects. The candidate will also ensure the timeliness and delivery of scientifically valid research.

Essential Functions

• Effectively designs and codes R and SQL programs for assigned project(s), consistently meeting objectives of the project.
• Clean and validate RWD for consistency and reliability
• Implement programming as specified from RWE protocol using a variety of RWD from multiple sources, including Optum and Flatiron
• Leverage advanced statistical and epidemiological methodologies to deliver robust and reliable analyses
• Create or review and approve programming plans at study and project level.
• Displays highly advanced knowledge regarding program, epidemiology methodologies implementation and system development life cycle concepts.
• Maintain clear documentation of analytical programming and operational definitions to support reproducible and auditable RWE studies
• Develop dashboards, reports, and presentations to communicate findings
• Work collaboratively with members of study teams to meet study and recurring report timelines

Minimum Requirements

• MS in data science, epidemiology, statistics, public health or related discipline
• At least 7 years of RWD analysis experience using healthcare claims/EMR/registry databases within the biopharmaceutical industry or provider/payer organizations
• Fluence in programming software SQL and R is required. Knowledge of SAS and/or Python would be considered an advantage
• Optum and Flatiron experience are required
• Familiarity with US and global health care coding system (e.g. ICD, CPT, HCPCS, LOINC, MedDRA) and delivery system (e.g. payers and reimbursement models)
• Experience conducting routine and advanced statistical analyses for RWE generation, leveraging time-to-event, cross-sectional, and longitudinal data
• Experience with big data analytical platforms
• Deep understanding of observational study analysis
• Able to work in a fast-paced, flexible, team-oriented environment