Senior Director, Clinical Development

Sr. Director, Clinical Development

The Sr. Director, Clinical Development is responsible for ethical, medical, and scientific rigor in supporting the development, conduct, and reporting of assigned clinical development portfolio across all stages of drug development and commercialization. This position is responsible for medical and scientific quality in the design, planning, initiation, and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development. As a leader of the Clinical Development department, this position may have line management accountability for Clinical Development staff.

Key Responsibilities

• Prepare clinical development plans according to the nature of the clinical project and its objectives: exploratory research, support a marketing authorization application, marketing and commercialization support, new indication, etc., ensuring that all aspects of ICH-GCP, medical devices guidelines/regulations and agreed quality standards are complied with at all times.
• Responsible for overall management of a product portfolio (i.e., multiple indications for the same product), as needed, based on the clinical development plan.
• Oversee protocol development from concept to final protocol. Protocol execution including interaction with key opinion leaders/investigator(s). May serve as sponsor contact for key study sites on protocol related topics.
• Serve as an escalation point for the Clinical Development team; participates in CRO Executive Governance meetings, as required.
• Serve as a mentor and provides line management for junior level staff, if required.
• Budgetary responsibilities for programs direct reports are overseeing.
• May serve as Medical Monitor or point of contact for CRO Medical Monitor for assigned clinical trials overseeing participant inclusion into the study. Provides back-up Medical Monitoring support for direct reports, as required.
• Write, edit, and review medical and scientific elements of both internal and external facing documents inclusive of clinical research, clinical development plans, operational and regulatory documents, including but not limited to study synopses, protocols, CRFs, informed consent templates, feasibility assessments, statistical analysis plans, clinical sections of regulatory documents (e.g., IND, MAA, NDA, PIP, DSUR, annual reports, regulatory designations, etc.), key study plans, and clinical study reports to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency.
• Lead responses to competent authority questions, as requested.
• Oversee study data reviews, liaise with data safety monitoring committees or other protocol directed committees, data analysis, and clinical study report authoring.
• Participate in the multi-disciplinary project team as the responsible individual of the project clinical development and presentation of the clinical trial results, aligned with Program Management when appropriate (teams and committees).
• Oversee/conduct ongoing medical and scientific review of clinical trial data with clinical scientific expert(s).
• Oversee creation and translation of Target Product Profile (TPP) into clinical strategy.
• Manage Key Opinion Leader and Medical Advisory Board interactions. Identify Key Opinion Leaders, as needed.
• Responsible for study medical/safety data aspects and risk-benefit assessments supported by Pharmacovigilance team.
• Ensure study quality and manage internal clinical activities. Assist Clinical Operations with supervision of activities of contract research organizations by reviewing key study plans and performance/quality and lead risk mitigation activities to ensure the timely delivery of study results and reports that comply with the applicable quality requirements. Escalate areas of concern to Clinical Development and Clinical Operations Heads as appropriate.
• Support business development activities, due diligence processes, and market access related to clinical development.
• Supervise clinical trial related activities delegated to/shared with Clinical Project Manager.

Required Skills and Qualifications

Education/Training:

• MD, DO, PhD, PharmD or equivalent degree or experience.

Previous Experience:

• At least 7-10 years of demonstrated clinical research and clinical development experience required, and experience working with all drug/medical device development phases, Infectious Disease experience preferred.

Abilities and Skills:

• Working knowledge of the assigned disease area with proven ability to interpret, discuss, and present efficacy and safety data relating to clinical trial(s).
• Working knowledge of region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.) and ICH GCP guidelines.
• Working knowledge of clinical trial design and statistics.
• Understanding of scientific methods and tools used in early clinical development, biomarkers, translational modeling, biostatistics, and relevant clinical trial landscape.
• Strong communication and oral presentation skills with the ability to work in a cross-functional and global organization.

• Highly organized and able to work within international environments with team members located in different locations/countries. Alignment with our Parent Company's group philosophy to contribute to life and living for people around the world through its group values and group vision.
• Able to seek and understand different perspectives, developing alternative solutions and valuing options suggested by others within the team.
• Able to understand and clarify boundaries of responsibility within own role and be able to allocate decision-making authority and task responsibilities to other team members as appropriate.
• Able to efficiently manage all tasks required during a study, to track multiple items, and provide guidance on the prioritization of tasks within a study.
• Ability to travel domestically and internationally, as required (approximately 25%)
• Strong project management and medical writing skills.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint) and Adobe Pro.

Compensation

The base compensation range for this role is $300-350K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.