- Provide clinical and scientific leadership for clinical and translational studies and asset-level programs
- Contribute to assessment of mechanisms and targets, target validation, life-cycle expansion, and innovative clinical development opportunities
- Develop and execute clinical development plans and align translational and clinical plans and study designs with project strategies
- Develop sections of core regulatory documents
- Generate data and evidence on efficacy, safety, differentiation, and route to medicine
- Define and deliver clinical pillars of the translational table
- Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism, and clinical efficacy endpoints
- Establish relationships with Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs, and Statistics counterparts
- Provide oversight of R&D evidence-generation strategy and study delivery
- Contribute to indication planning, target validation, translational plans, candidate selection, and the early medicine profile
- Design clinical development plans, protocols, and associated documents across development phases
- Support regulatory interactions, briefing documents, presentations, and responses
- Provide medical monitoring and safety oversight of study participants with the Pharmacovigilance Physician
- Ensure medical governance, scientific integrity, and subject safety across studies
- Lead the Clinical Matrix Team for a program
- Serve as the clinical point of contact for indications, investigational agents, and clinical studies
- Lead end-to-end clinical development strategy for early programs and contribute to later stages
- Engage regulatory agencies, key opinion leaders, clinical investigators, internal review boards, and Protocol Review Boards
- Assist with clinical evaluation of business development opportunities
- Monitor research, trial methodologies, competition, and regulatory developments
- Identify transformational opportunities and contribute to Medicine Profile clinical components
- Solve study and clinical development challenges and influence project and departmental decisions
- Create innovative scientific and technical solutions using new learning and digital tools
- Inspire others, manage conflict, and collaborate across the matrix
- Analyze complex data, anticipate obstacles, assess risks, and make informed decisions
Requirements
- Medical Degree
- Completion of formal postgraduate clinical training, clinical residency, or specialty training in Internal Medicine, Pathology, or similar
- Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
- Strong working knowledge of clinical development processes, GCP, ICH guidelines, and global regulatory frameworks
- Ability to apply clinical judgment to study design, patient safety, and real-time medical decision-making
- Experience operating within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
- Strong scientific communication skills and ability to translate clinical data into clear insights
- Preferred: advanced specialty training, fellowship, or country-equivalent higher-level qualification leading to formal specialist recognition, board certification, or country-specific professional designation
- Preferred: pharmaceutical or biotechnology clinical development experience across early-phase studies
- Preferred: clinical experience in relevant specialties or therapeutic areas with direct clinical research or drug development exposure
- Robust knowledge of aging research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guideline evolution
- Knowledge and experience executing clinical and/or translational studies, generating and analyzing human translational data, and conducting preclinical biological experiments
- Experience working with global regulatory agencies and managing global clinical trials
- Prior experience contributing to IND, CTA, NDA, BLA, or MAA submissions
- Experience engaging Key External Experts, investigators, and scientific collaborators in aging disease areas
- Ability to work collaboratively in cross-functional teams and matrix environments to design and execute trials to regulatory standards
Core Competencies
Demonstrates expertise in clinical development processes, regulatory frameworks, and scientific communication, with a strong focus on patient safety and innovative study design. Proven ability to lead cross-functional teams and engage with regulatory agencies to drive clinical and translational studies.
#J-18808-LjbffrMedical Director – Clinical Development, Aging in california at Unknown Company
This position is listed as full time and onsite.