Sr Director, Clinical Development

Role Summary

The Sr. Director, Clinical Development will have multiple responsibilities as a hands on leader in the Clinical Development function who makes strategic contributions across the portfolio and the business. They will provide leadership and oversight while also developing and ensuring effective and efficient execution of the clinical development plan (CDP).

The individual will also be responsible for Program Team Lead (PTL) activities, managing one or more programs by leading multidisciplinary/cross-functional teams from relevant expert functions, as part of the company’s strategy.

Responsibilities

• Provides strategic leadership and oversight for the design, execution, and delivery of clinical development programs in support of CDP including document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review process, and other deliverables as needed.
• Shapes and drives the development of strategic clinical initiatives, including:
  • Development of disease area strategy, target product profile (TPP), and/or clinical development plans.
  • Applies deep therapeutic area and clinical development expertise to influence enterprise-level program decisions.
• Oversees and interprets clinical data at the portfolio level; ensures insights inform regulatory strategy, publications, and corporate goals.
• Stays abreast of internal and external developments, trends and other dynamics relevant to the work to maintain a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• Demonstrates hands-on leadership in all aspects of clinical development, actively engaging with cross-functional teams to ensure strategic alignment, operational excellence, and timely execution of program deliverables.
• Leads clinical development efforts in infectious disease, leveraging deep expertise in prevention-focused strategies to design innovative trials, inform regulatory interactions, and accelerate program advancement in high unmet need populations.
• Responsible for effective and efficient execution of the CDP from protocol development to study close out for assigned molecule(s)/indication, with responsibility for risk/benefits assessments, scenario planning, and program-level decision making.
• Attends and contributes, as needed, at meetings with Health Authorities (HAs) related to clinical programs; develops responses to HAs and IRBs on clinical questions.
• Effectively represents the company with cooperative groups/alliance partners, key opinion leaders, or other internal and external stakeholders to both offer and gather scientific/clinical consultation.
• For critical programs, serve as Program Team Leader, responsible for:
  • Hands on leadership driving cross-functional alignment and integration of strategy, timelines, budgets, and value creation for the Target Product Profile.
  • Acting as the voice of the project team, communicating key updates, risks, and opportunities to executive leadership.
  • Anticipating and mitigating program risks and identifying strategic opportunities.
  • Detailing Go/No Go criteria and scenario planning.
• Builds organizational capability, and fostering a culture of scientific rigor, operational excellence and innovation.

Qualifications

• 15+ years pharma/biotech industry experience
• At least 10 years’ of hands-on experience in clinical trial design, execution and oversight across Phase I-III programs
• Extensive knowledge of clinical research methodologies and global regulatory requirements (GCP, ICH, FDA, EMEA, NICE)
• Demonstrated success leading multifunctional teams and managing external partners, including CROs
• Therapeutic experience in Ophthalmology and/or infectious disease (including Lyme disease) beneficial
• Experience working across research, clinical, non-clinical development and commercial functions to align strategy and execution
• Excellent communication and collaboration skills, with a proven ability to influence stakeholders and foster a culture of teamwork

Education

• Advanced clinical/science degree preferred (MD, PharmD, PhD, or other)

Additional Requirements

• Based in Irvine office with hybrid work environment; remote work option available
• Some travel may be required – up to 30%