Clinical Development Medical Senior Director

Role Summary

The Clinical Development Medical Senior Director leads innovative approaches to clinical development, serves as a subject matter expert, and influences senior leadership decisions. They may lead cross-functional teams and governance or advisory committees, ensuring medical and scientific integrity and the wellbeing of trial participants. They design and execute high-quality studies, maintain compliance and risk management, and guide interpretation and communication of clinical data. They act as the primary clinical/medical contact for protocol aspects and support strategic development and matrix management.

Responsibilities

• Leadership
  • Autonomously and independently leads clinical execution of one or more studies of high complexity and significant business impact. May be accountable for program level clinical deliverables.
  • Leads innovative approaches to clinical development, develops options and oversees implementation of solutions for complex problems.
  • May lead or chair cross functional teams at the category or portfolio level including governance or advisory committees.
  • Provides matrix management to clinical colleagues or a cross-functional team in clinical development.
• Content Creation
  • Provides clinical/medical input to support development of the protocol design document (PDD).
  • Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant/site engagement and minimize amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.
  • Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Informed Consent and Safety Oversight
  • Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
  • Clinical & Safety Oversight.
• Monitoring and Data
  • Performs medical monitoring on one or more clinical trials.
  • Provides study-related medical information and assistance (e.g., questions from investigators/site personnel/non-study health care providers; safety findings; complex adverse events; audits/inspection responses).
  • Provides clinical/medical input to the development of data collection tools.
  • Provides clinical/medical input to SAP, TLFs and BDR.
  • Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
  • Provides clinical/medical input to the Integrated Quality Management Plan (IQMP); reviews and approves the final document.
  • Inputs to, reviews, and approves Risk Management and Safety Review Plan; ensures activities are conducted per the approved plan and develops mitigations with stakeholders.
  • Reviews country/site selection, develops site selection criteria, and contributes to site training materials.
  • Serves as the primary contact with external investigators and internal study team for clinical/medical questions relating to the protocol.
  • Contributes to final significant quality event medical assessments.
  • Jointly conducts periodic safety data reviews and ongoing clinical/medical data review with clinical colleagues.
  • Reviews required safety text and endorses significant medical changes in the ICD.
  • Reviews, reports and manages protocol deviations; reviews patient-level and cumulative data per the data review plan; reviews safety data, SAE reports, TME/DME, and ensures clinical documents are updated as required.
  • Tracks and reconciles SAEs across a study and leads presentation of data during Safety Review Team meetings.
  • Ensures TMF compliance for clinical documents.
• Clinical Reporting
  • May contribute to clinical sections of regulatory filings and regulatory authority responses if required.
  • May support responses to regulatory queries and Clinical Trial Applications (CTAs).
  • Inputs and reviews the Clinical Study Report, including narrative review; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publication of clinical trial results.
  • Provides clinical support to the study team or clinical program in response to audits or inspections.

Qualifications

• Required: Primary medical degree (MD, DO, MBBS, MBChB) and 7+ years of experience in biopharmaceutical clinical research and development.
• Required: Licensed to prescribe medicines independent of supervision for at least 2 years post intern/house officer/foundation period.
• Required: Maintained Medical License in good standing with the Medical Licensing Authority.
• Required: Clinical research experience in phase 3/pivotal space.
• Required: Demonstrated scientific writing skills; publications, posters, abstracts, and/or presentations.
• Required: Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
• Required: Demonstrated clinical/medical, administrative, and project management capabilities, with excellent verbal and written English communication; ability to relate to individuals inside and outside the organization.
• Required: Demonstrated experience establishing, managing, and training teams in clinical development.
• Preferred: Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.).
• Preferred: Breadth of leadership experiences including influence and collaboration, coaching, and guiding others to achieve meaningful outcomes and business impact.
• Preferred: Passion for helping patients.
• Preferred: Proven analytical skills with large data sets.
• Preferred: Effective communication, presentation, and organizational skills for coordinated and timely delivery.
• Preferred: Demonstrated scientific writing skills and excellent English communication.
• Preferred: Global perspective and ability to work in diverse, cross-cultural teams; effective with internal and external partners and investigators/medical professionals.
• Preferred: Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance).
• Preferred: Proficiency with IT and telecommunications; ability to adapt to changing environments while maintaining integrity and quality.
• Preferred: Demonstrates problem-solving, agile decision-making, collaboration, and leadership behaviors; ability to communicate results and build partnerships; promotes innovation and accepts appropriate risks; ability to work proactively and independently.

Additional Requirements

• Global travel might be required.
• Relocation support available.