Job Title: Early Development Project Leader

Location: Morristown, NJ

About the job:

The Early Development Project Leader provides strategic input into the early global development plan as well as directs, supervises and manages all operational aspects of global clinical early projects (e.g. pre-candidate to POC/POCC) and 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 Early Development Project Leader is expected to be able to effectively lead several early complicated program developments with minimal guidance. The Early Development Project Leader is the main partner between the global project team and the larger operations group and manages project deliverables on a day-to-day basis. The Early Development Project Leader is accountable for ensuring deliverables through effective program/project management, using his/her business acumen and people skills to lead programs in an effective and agile manner.

Early Development Project Leader is considered to be a very experienced Project Leader, able to work independently and manage several early programs at different stages.

Main responsibilities:

• Operational strategy & execution: Responsible for providing input into the early operational strategy, prepares operational assumptions at project level to support development of global study budgets, and accountable for development of operational plans, with input from all applicable functions within the CSO, in order to propose the optimal early clinical operations solutions and scopes of work that creates the most value for the project and company.
• Accountable for ensuring the study/program performance within the CSO and for driving the multi-disciplinary CSO project team according to project requirements & defined project objectives to create the most value for the project.
• Represents CSO when collaborating and goal setting with other functions and across projects, enabling functions to successfully meet the requirements, milestones, and deliverables of the clinical development plan as defined by the GPT.
• Contribute to CSO business expansion and innovation.
• Identify opportunities for improving organizational processes to continue to drive organizational and operational excellence.

Specific to early development:

• Previous and strong experience in early project and clinical development from entry to development to First In Human to POC
• Previous and strong experience in Dose Escalation, Dose Optimization and Dose expansion + any complex design
• Familiar with all pre-clinical activities (e.g. Toxicity studies)
• Collaborates upfront with CSCO, Demand and Supply Leader and CMC Leader in order to secure all aspects linked to IMP (e.g: in use study anticipation, pharmacy manual, IP delivery)
• Supports BM development in collaboration with BMOM and TMED.
• Collaborates with main stakeholders from TMU (e.g. ECET, PK, BCB), TA and CSO (e.g. ECB) during the development/definition of the FIM to POC studies.
• Responsible for optimizing the early development operational strategy, implementation and realization of FIH to POC/POCC studies based on input from all applicable functions within the CSO, in order to create the most value for the project team and the platform for operational tasks
• Steering the program from research into global clinics, until hand off to registration and Late Development ensuring smooth, fast, efficient, agile, and expertise-preserving transfer to the late development teams (GCO).
• Support to late stage compound, pilot and coordinate early activities : including Phase I, new POC indications and complex design studies. Be the primary point of contact for late phase development teams.

About You:

Basic Qualifications:

Education:

• Bachelor's, Master's, PhD or PharmD in Life Sciences, Clinical Research, Pharmacology, Pharmaceutical Sciences, or related discipline

Experience:

• 8+ years (Bachelor's), 5+ years (Master's), or 3+ years (PhD/PharmD) 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, or neurology therapeutic areas
• Experience in other therapeutic areas such as oncology or immunology
• 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

Additional Skills:

• Data Management skills - 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 skills - ability to lead teams without direct line management authority
• Problem Solving skills - handling complex, ambiguous situations with agility
• Vendor Management skills - managing CROs and external partners effectively

Why Choose Us:

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Achieve genuine work-life balance in a supportive R&D environment.

The salary range for this position is:
$148.500,00 - $214.500,00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.