Senior Director, Clinical Development, Oncology

Role Summary

Senior Director, Clinical Development, Oncology leading the clinical development program for one or more mRNA-based precision immunotherapies in early-phase development. Reports to the Head of Early Clinical Development, Oncology with direct medical responsibility for clinical development plans, study design, protocols, execution, and medical monitoring, collaborating with internal and external partners and CROs.

Responsibilities

• Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets.
• Integrate scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP.
• Generate data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Establish expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
• Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas as needed.
• Contribute to and partner with the development of strategic initiatives, such as organizational initiatives within Clinical Development.
• Play an active role in the technical and leadership development of Clinical Scientists.
• Employ visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s); lead selected clinical development projects.
• Lead and influence across external experts (regulators, payors, CROs, consultants, investigators) to deliver integrated clinical development strategy aligned to business goals and patient need.
• Integrate inputs across disciplines to contribute to the Target Product Profile and be accountable for clinical components of the TPP.
• Accountable for risk/benefit of the asset; lead decisions balancing risk/benefit at the project level with impact on approvals; mitigate risk where appropriate.
• Evaluate therapies across patient populations/indications for potential broader use.
• Anticipate problems and seek input from team members to solve study/project-related issues using scientific/operational expertise.
• Oversee the evaluation of clinical study/program probability of technical success.
• Drive end-to-end integrated clinical development strategy to achieve regulatory approvals, reimbursable medicines, and lifecycle management.
• Lead clinical development discussions at regulatory interactions and clinical submissions (IND, NDA, BLA, MAA) including briefing documents and responses.
• Deliver insights to inform medical strategy, expand market access and address unmet patient need.
• Overcome obstacles by adopting new ways of working, including digital tools and technology; champion innovative methods and processes within clinical development.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent with relevant hematology and/or oncology experience in an academic or hospital environment.
• Experience in oncology drug development with at least 3 years in the biopharmaceutical industry; exceptions considered for at least 5 years as an early-phase clinical trialist in academia.
• Medical oncology and/or hematology fellowship training preferred.
• Experience in oncology and/or hematology immunotherapeutics preferred.
• Experience in conducting translationally rich oncology/hematology clinical trials highly valued.
• Proven track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
• Outstanding verbal and written communication skills; excellent organizational skills.
• Understanding of the entire drug development process, including clinical and non-clinical study design and execution.
• Thorough understanding of clinical research methodology and biostatistics principles to enable innovative trial design and data-driven decision rules.
• Experience overseeing internal cGCP audits and regulatory inspections related to clinical trial conduct.
• Strong knowledge of FDA, MHRA and ICH GCP guidelines to ensure appropriate conduct of clinical studies globally.
• Attention to detail, drive to generate high-quality work, and urgency to achieve goals.
• Experience managing complex projects and collaborating with multiple stakeholders to ensure consistent communication.
• Experience using digital tools to drive innovation in clinical development.
• Strong analytical, problem-solving and strategic planning skills.
• Ability to thrive in a fast-paced environment; embodies core values of Bold, Relentless, Curious and Collaborative.