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Clinical Development Lead
3 weeks ago
In this pivotal role, you will oversee the end-to-end clinical development process for assigned programs within a specific therapeutic area. Your expertise and leadership will ensure the seamless execution of clinical development plans while fostering a culture of empowerment, agility, and collaboration within a dynamic matrixed environment.
Primary Accountabilities
- Providing clinical leadership and strategic medical input for all clinical deliverables in assigned projects or sections of clinical programs.
- Leading the development of clinical sections of trial and program level regulatory documents.
- Ensuring the successful execution of assigned clinical programs and/or clinical trials in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable.
- Supporting (Senior) Global Program Clinical Heads (GPCHs) in ensuring overall safety of molecules for assigned sections and acting as core members of Safety Management Teams (SMTs), supporting overall program safety reporting in collaboration with Patient Safety colleagues.
- Supporting Clinical Development Heads (CDHs) and GPCHs by providing medical input into Clinical Development Plans (CDPs), Integrated Development Plans (IDPs), and Clinical Trial Protocol (CTP) reviews, and contributing to/driving the development of disease clinical standards for new disease areas.
- As medical experts, supporting (Sr.) GPCHs or CDHs in interactions with external and internal stakeholders and decision boards.
Required Experience
- MD or equivalent medical degree is required, along with advanced knowledge and clinical training in a medical/scientific area.
- Clinical practice experience (including residency) and board certification or eligibility in a disease area are preferred.
- Extensive experience in clinical research or drug development is required.
- Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV is necessary.
- Experience of contributing to and accomplishing all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environment in the pharmaceutical industry is required.
- Working knowledge of a disease area is necessary, along with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trials and understand and interpret basic and clinical scientific research reports.
- Demonstrated ability to establish effective scientific partnerships with key stakeholders.
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
- Previous global people management experience is preferred, though this may include management in a matrix environment.
Commitment To Diversity & Inclusion
The organization is committed to building an outstanding, inclusive work environment and diverse teams representative of patients and communities served.
Accessibility And Accommodation
The organization is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please let us know and include your contact information.
