Executive Director - Clinical Development

Eli Lilly and Company; United States; Remote; USD 201,000 - 356,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, seeks an Executive/Senior Director, Clinical Development to lead early‑stage orexin receptor 2 programs from preclinical translation through late‑stage trials, coordinating across Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, Safety and external partners.

The ideal candidate holds an MD in neurology or psychiatry, 8+ years in pharma, translational medicine expertise, and proven capability to

Qualifications

• MD in neurology or psychiatry, board-certified preferred
• 8+ years of pharmaceutical industry experience
• Experience in early-to-late clinical development with regulatory submissions

Responsibilities

• Lead clinical study design and execution for early-stage programs.
• Oversee CDPs spanning preclinical to late-stage trials.
• Ensure regulatory expectations are met across studies.
• Collaborate with Clinical Operations, Translational Medicine, Biostatistics, Safety and external partners.
• Provide real-time medical and scientific guidance for ongoing trials, including data review and safety oversight.
• Support biomarker strategy and dose selection within translational groups.
• Prepare, write and review regulatory submissions and clinical study reports.

Skills

Clinical leadership

Cross-functional collaboration

Regulatory interactions

Translational medicine

Strategic thinking

Communication skills

Team management

Remote work adaptability

Education

MD in neurology or psychiatry

Job description

About Lilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical‑stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep‑wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical‑stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work in 2026. The Executive/Senior Director, Clinical Development will play a leadership role in advancing Centessa’s clinical programs in CNS indications. Reporting to the Associate Vice President, Clinical Development, this role will provide leadership for the strategic and operational execution of the company’s early‑stage Orexin Receptor 2 Agonist Programs, which includes targets in neurological and neurodegenerative disorders. Given the broad pipeline within the organization, the Senior Director must bring experience spanning preclinical through late‑stage clinical development, with the ability to shift fluidly across programs as priorities change. In this highly visible, hands‑on role, the Senior Director will collaborate closely with cross‑functional partners across Clinical Operations, Regulatory Affairs, Translational Medicine, Biometrics, Safety, and external stakeholders. The individual will provide scientific and medical leadership for clinical study design, execution, data interpretation, and regulatory interactions. This role requires a collaborative and agile mindset, exceptional communication skills, and the ability to influence across a matrixed organization.

Responsibilities

• Serve as a clinical leader for assigned early‑stage program(s), providing medical and scientific ownership, while maintaining readiness to support later‑stage or emerging programs.
• Author and oversee clinical study protocols for orexin receptor agonists, ensuring scientific rigor, operational feasibility, and alignment with regulatory expectations.
• Contribute to and help develop integrated clinical development plans (CDPs) spanning preclinical translation through late‑stage trials, enabling efficient advancement of multiple candidate molecules.
• Collaborate closely with Clinical Operations to meet quality, timeline, and budget expectations across all studies within the assigned program(s) and other CNS programs as needed.
• Provide real‑time medical and scientific guidance for ongoing clinical trials, including data review, safety oversight, and acceleration of development programs.
• Partner with our translational groups to support biomarker strategy, dose selection, and evaluation of indication expansion opportunities.
• Communicate clinical and scientific updates clearly across internal teams and external stakeholders.
• Contribute to the preparation, authorship, and review of clinical sections of regulatory submissions, including INDs, protocol amendments, briefing documents, annual reports, safety reports, and clinical study reports.
• Ensure robust oversight of safety monitoring and adherence to Good Clinical Practice (GCP), pharmacovigilance standards, internal SOPs, and quality requirements.
• Support regulatory interactions with global health authorities, including preparation for key meetings, responses, and ongoing communication.
• Provide oversight of study integrity, safety, efficacy data, and risk‑benefit assessments across assigned programs.
• Ensure that clinical insights and external evidence are synthesized and used to guide strategic decision‑making across the portfolio.

Ideal for those seeking

• The opportunity to lead an early‑stage asset with the potential to transform standard of care for individuals living with neurpsychiatric and neurodegenerative disorders.
• A role within a lean, fast‑paced, growth‑oriented biotech environment requiring deep CNS expertise
• A collaborative, science‑driven, and patient‑focused culture
• A remote working environment with high visibility and strategic impact

Basic Qualifications

• MD in neurology or psychiatry (board certification preferred)
• Clinical and/or academic experience in neurological disorders; and 8+ years of pharmaceutical industry experience
• Translational medicine expertise highly desired
• Experience in early clinical development through late stage with successful design and implementation of proof‑of‑concept studies; submission experience in the neuroscience area is desired.
• Knowledge of US and EU regulatory guidelines and experience in interactions with regulatory agencies
• Outstanding written and verbal communication, with a passion for problem solving and effective cross‑functional stakeholder engagement.
• Ability to work independently and thrive in a fast‑paced dynamic matrix environment.
• An entrepreneurial spirit with high degree of energy and personal accountability

Work Location

The Executive / Senior Director, Clinical Development role is a remote position based in the US, with approximately 15% travel. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

EEO/Employer Statement

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Compensation

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $201,000 - $356,400 Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a 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; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

Benefits

• 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)