Clinical Sciences Trial Leader (Trial Leadership) – Translational Medicine, Clinical Pharmacology (80-100%)

Novartis

Basel

Hybrid

CHF 94,000 - 174,000

Full time

11 days ago

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Benefits offered by this job

Hybrid working options
Parental leave (14+ weeks)
Wellbeing resources

Job summary

Novartis AG in Basel seeks a Clinical Sciences Trial Leader (CSTL) to lead clinical pharmacology trials, including FIH studies, ensuring high-quality data for key program decisions. You will bridge Novartis with CROs, guiding protocol development, study start-up, conduct, and CSR delivery.

The role emphasizes hands-on leadership, cross-functional collaboration, and a strong commitment to scientific and operational excellence, with flexible Basel-based hybrid work安排.

Qualifications

  • Bachelor’s degree in life sciences or healthcare required; MSc/PhD/PharmD/MD or equivalent preferred.
  • Experience in clinical pharmacology or early clinical development, ~2+ years.
  • Demonstrated experience leading first-in-human and/or clinical pharmacology studies.
  • Strong protocol development and early phase study design skills.
  • Proven ability to deliver studies through external partners (CROs).
  • Strong study leadership and cross-functional coordination in a matrix environment.
  • Excellent communication and stakeholder management; ownership and accountability.
  • Solid understanding of ICH GCP and regulatory requirements.

Responsibilities

  • Provide operational leadership for clinical pharmacology studies, including FIH and early-phase trials.
  • Act as independent CSTL for end-to-end study delivery from protocol to CSR.
  • Lead protocol synopsis development with cross-functional partners.
  • Serve as primary Novartis CRO contact with guidance and oversight.
  • Coordinate internal study teams to align CRO activities.
  • Oversee study start-up, conduct, and closeout with risk mitigation.
  • Review clinical study data (PK/PD/safety) to inform decisions.
  • Contribute to CSRs and program updates with scientific rigor and traceability.
  • Share lessons learned and foster collaboration and accountability.

Skills

Clinical pharmacology
Early clinical development
Protocol development
Study delivery
CRO management
Cross-functional leadership
Data interpretation
Regulatory knowledge

Education

Bachelor’s degree in life sciences or healthcare
Advanced degree (MSc, PhD, PharmD, MD) preferred

Job description

Salary Range

CHF93,800.00 - CHF174,200.00

Band

Level 4

Job Description Summary

Location: Basel, Switzerland
LI#-Hybrid

We are seeking a Clinical Sciences Trial Leader (CSTL) to join Clinical Sciences & Innovation (CS&I) – Translational Medicine, in the Clinical Pharmacology team in Basel.

This position plays a critical role in the delivery of first-in-human (FIH) and clinical pharmacology studies, representing a major step in the development of new medicines. You will be accountable for the scientific and operational leadership of clinical pharmacology trials, typically conducted in healthy volunteers, ensuring high quality, interpretable data to inform key program decisions.

The CSTL role in Clinical Pharmacology is distinct in its strong focus on delivery through others. You will act as the primary bridge between Novartis and the qualified Contract Research Organizations (CROs) conducting clinical pharmacology studies, providing clear direction, oversight and integration from protocol development through to Clinical Study Report (CSR) delivery. This is a highly collaborative, hands‑on role, requiring strong study leadership, excellent communication skills and confidence operating at the interface between internal teams and external partners.

This position is based in Basel, with flexibility to work remotely for up to two days a week. Domestic and international travel may be required to support investigator meetings, study team engagement and trial oversight. Work permit support cannot be offered for this role.

Job Description
Key Responsibilities
    • Provide operational leadership for assigned clinical pharmacology studies, including first-in-human and other early phase healthy volunteer trials.
    • Act as independent Clinical Sciences Trial Leader in the Clinical Pharmacology team, accountable for end-to-end‑ study delivery from protocol development through to CSR finalization.
    • Lead the clinical pharmacology protocol synopsis development process, serving as responsible author in close collaboration with Medical, Pharmacokinetics, Biomarker, Statistics and other cross‑functional‑partners to deliver the protocol synopsis that forms the basis for the selected CRO to develop into a full protocol.
    • Serve as the primary Novartis point of contact to the CRO, providing guidance, oversight and challenge to ensure high quality‑study conduct and delivery.
    • Lead and coordinate internal cross‑functional study teams, ensuring effective integration of inputs and alignment with CRO activities.
    • Oversee study start‑up, conduct and closeout, including review of key deliverables, issue management and risk mitigation.
    • Lead the ongoing review of clinical study data, including emerging PK, PD and safety data, supporting timely interpretation and decision making, e.g. for dose escalation decisions.
    • Contribute to Clinical Study Reports (CSRs), internal decision documents and program updates, ensuring clarity, scientific rigor and traceability.
    • Share lessons learned and contribute to continuous improvement of clinical pharmacology study delivery.
    • Act as a strong role model within study teams, fostering effective collaboration, accountability and high standards of scientific and operational excellence.
Essential Requirements
    • Bachelor’s degree in life sciences or healthcare required; advanced degree (MSc, PhD, PharmD, MD or equivalent) preferred.
    • Experience in clinical pharmacology, early clinical development or clinical trial delivery, ideally within a pharmaceutical environment, for ~2+ years
    • Demonstrated experience contributing to or leading first-in‑human and/or clinical pharmacology studies, including healthy volunteer trials.
    • Strong experience in protocol development, early phase‑ study design and clinical data interpretation, particularly PK/PD and safety data.
    • Proven ability to deliver studies through external partners, with experience working closely with CROs and managing outsourced trial conduct.
    • Strong study leadership and coordination skills, with the ability to align diverse stakeholders and drive delivery in a matrix environment.
    • Comfortable operating with a high degree of personal ownership and accountability, managing complexity and ambiguity inherent in early phase‑development.
    • A clear growth mindset, with interest in developing own capabilities and contributing positively to team effectiveness and the wider CSI culture.
    • Solid understanding of ICH GCP, regulatory requirements and high‑quality clinical trial conduct, particularly in the context of FIH studies.
Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role:

93,800.00 - 174,200.00 CHF Annual

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

  • In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
  • We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
  • Long‑term equity awards granted at group level may also be part of
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