[Hiring] Senior Director, Clinical Development @Lilly

Role Description

The (Senior) Director, Clinical Development will play a critical leadership role in advancing our clinical programs in sleep-wake disorders and broader CNS indications. Reporting directly to the Associate President, Clinical Development, this leader will assume primary responsibility for the strategic and operational execution of the company’s late-stage Orexin Receptor 2 Agonist Program (Program 750), which targets narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.

Responsibilities

• Primary point of contact for clinical development activities with willingness to work strategically and hands-on at the program and clinical trial levels.
• Accountable for the oversight, monitoring, and surveillance of overall risk, safety, benefit/efficacy to patients as well as compliant trial execution and optimal integrity of data.
• Responsible for establishing relationships and communication with KOLs, investigators, and relevant site medical (or other supportive roles) personnel.
• Lead the clinical development strategy and innovative approaches for the overall clinical pathway for the asset.
• Key clinical development contributor to publication strategy and planning, authoring of publications, posters, etc., and present or support presentations, posters, etc., in conferences and meetings.
• Play a key role in regulatory and health authority interactions.
• Lead clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, ad hoc safety reports (SUSARs), interim and final CSRs, etc.
• Author asset and clinical trial level plans, charters, documents.
• Determine optimal clinical trial design options that are innovative, patient-centric, cost-efficient, and enable meeting business goals.
• Responsible for review, analysis, and interpretation of all clinical trial data including assessment of protocol deviations.
• Lead asset level clinical sub-teams and play key leadership role on program team for clinical development.
• Lead asset level and trial level medical forums as needed (safety review committee, ad board, KOL meetings, medical review/discussions of patient cases, cohort review meetings, etc.).
• Attend and present as needed at core team meetings, investigator meetings, site visits, etc.
• Liaise with cross-functional partners, vendors, and CROs to ensure the progression of clinical studies within the expected time frame.
• Provide clinical evaluation and interpretation of pre-clinical results.
• Remain current on the development of orexin agonists and the relevant therapeutic areas through review of the scientific literature, interactions with KOLs and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of Centessa clinical stage programs.

Qualifications

• MD required, MD/PhD strongly preferred (includes internationally recognized equivalent).
• Minimum 5 years of combined experience across academia, clinical practice, pharma/biotech industry, etc.
• Minimum 2 years of pharmaceutical/biotech industry experience, including managing clinical development programs and clinical trials.
• Substantial experience supporting CNS / neuroscience drug development required; sleep medicine and associated therapeutic areas strongly preferred.
• Willingness to deliver project and tactical level work.
• Excellent working knowledge of regulations across various agencies (FDA, EMA, etc.) and GCP, & ICH guidelines. Knowledge or experience supporting regulatory or health authority inspections a plus.
• Experience leading and authoring clinical development inputs into regulatory submissions (IND, CTAs, NDA/BLAs, designation applications, etc.) and representing clinical development in agency interactions.
• Experience authoring and guiding teams with key asset and clinical trial level plans and documents.
• Strong knowledge in clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc.
• Possess excellent written and oral communication skills with internal and external stakeholders.
• Proven ability to work collaboratively, take initiative, solve complex issues, and deliver results in a fast-paced, team-based matrix environment.
• Demonstrate sound judgment in handling complex, confidential, and highly regulated information.
• Ability and willingness to travel as required.

Work Location

The (Senior) Director, Clinical Development role is a remote role based in the US, with occasional travel.

Benefits

• Comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).