Early Development Project Leader

About the role

The Early Development Project Leader provides strategic input into the early global development plan and directs, supervises, and manages all operational aspects of global clinical early projects (e.g., pre-candidate to POC/POCC). This role is accountable for ensuring quality deliverables on time and within budget. The Early Development Project Leader is a core member of the Global Project Team (GPT) and co-manages the Clinical Sub-Team (CST) (or the Joint Clinical Operations Team (JCOT) if applicable).

The role requires leading several early, complicated program developments with minimal guidance and serving as the main partner between the global project team and the larger operations group. The Early Development Project Leader ensures deliverables through effective program/project management, leveraging business acumen and people skills to lead programs in an agile manner.

We are an innovative global healthcare company focused on chasing the miracles of science to improve people’s lives. This role is ideal for a very experienced Project Leader who can work independently and manage multiple early programs at different stages.

Responsibilities

• Provide input into the early operational strategy and prepare operational assumptions at the project level to support global study budget development.
• Develop operational plans with input from applicable functions within the CSO to propose optimal early clinical operations solutions and scopes of work.
• Ensure study/program performance within the CSO and drive the multi-disciplinary CSO project team according to project requirements and objectives.
• Represent the CSO in collaborations and goal-setting with other functions and across projects to meet clinical development plan milestones and deliverables.
• Contribute to CSO business expansion and innovation by identifying opportunities for improving organizational processes.
• Leverage strong experience in early project and clinical development, including dose escalation, dose optimization, and dose expansion studies, as well as complex designs.
• Collaborate with pre-clinical teams (e.g., Toxicity studies) and stakeholders such as CSCO, Demand and Supply Leader, and CMC Leader to secure all aspects linked to IMP (e.g., in-use study anticipation, pharmacy manual, IP delivery).
• Support biomarker development in collaboration with BMOM and TMED.
• Collaborate with TMU (e.g., ECET, PK, BCB), TA, and CSO (e.g., ECB) during the development/definition of FIM to POC studies.
• Optimize the early development operational strategy and implementation for FIH to POC/POCC studies based on input from applicable CSO functions.
• Steer the program from research into global clinics until handoff to registration and Late Development, ensuring a smooth, fast, and efficient transfer to late development teams.
• Support late-stage compounds by piloting and coordinating early activities, including Phase I, new POC indications, and complex design studies.
• Serve as the primary point of contact for late-phase development teams.

Qualifications

Basic Qualifications:

• Bachelor’s, Master’s, PhD, or PharmD in Life Sciences, Clinical Research, Pharmacology, Pharmaceutical Sciences, or a related discipline.
• 8+ years (Bachelor’s), 5+ years (Master’s), or 3+ years (PhD/PharmD) of experience in pharmaceutical or biotech clinical development or clinical operations. Academic or research experience will be considered.
• Experience in clinical trial management or project management in a pharmaceutical/biotech setting.
• Proven ability to work independently with minimal supervision.
• Experience in cross-functional collaboration with multiple stakeholders.

Preferred Qualifications:

• Early development operational experience (Phase I, First-in-Human, Proof of Concept studies). Candidates with late-stage experience will also be considered.
• Experience managing clinical programs (not just individual studies).
• Experience with dose escalation, dose optimization, and dose expansion study designs.
• Experience in rare diseases, ophthalmology, neurology, oncology, or immunology therapeutic areas.
• International background or experience managing global clinical trials.
• Field monitoring experience or hands-on site management experience.
• Experience managing multiple complex programs simultaneously.
• Experience coordinating with supply chain, CMC (Chemistry, Manufacturing & Controls), and biomarker teams.
• Experience managing smooth handovers between early and late-stage development teams.

Skills

• Data Management: Understanding of clinical data flow and quality.
• Familiarity with agile project management methodologies.
• Familiarity with ICH-GCP guidelines and global regulatory requirements.
• Experience with clinical trial management systems and project management tools.
• Knowledge of biomarker development and companion diagnostics.
• Leadership: Ability to lead teams without direct line management authority.
• Problem-solving: Handling complex, ambiguous situations with agility.
• Vendor Management: Managing CROs and external partners effectively.

Benefits

• Supportive, future-focused team environment with opportunities for career growth through promotions or lateral moves, domestically or internationally.
• Comprehensive rewards package recognizing contributions and amplifying impact.
• Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Work at the forefront of drug discovery using cutting-edge AI, data, and digital platforms.
• Opportunity to improve the lives of millions globally by accelerating drug development.
• Genuine work-life balance in a supportive R&D environment.