Medical Director

About the role

The Medical Director will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s).

Responsibilities

• Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio.
• Apply medical expertise to guide query resolution, adjudication of outliers, and clinical plausibility review during data cleaning.
• Collaborate with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements.
• Lead clinical science aspects of the clinical development strategy and clinical documentation.
• Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.
• Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings.
• Support the Medical Monitors, Medical Lead, and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs).
• Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents.
• Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data.
• Lead clinical data review meetings, escalating issues and recommending solutions to maintain data reliability and consistency.

Requirements

• M.D. (or equivalent international medical degree, MBBS, MBChB,) with board certification/eligibility in Oncology; with subspecialty training in GI malignancies (strongly preferred).
• Minimum 5+ years’ experience in clinical development required in solid tumors generally, and GI Tumors (strongly preferred).
• Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities within the biotech/pharmaceutical industry.
• Demonstrated experience with medical data review, cleaning for NDA or BLA filings and regulatory submissions.
• Strong working knowledge of data cleaning, database lock processes, and clinical data review.
• Prominent ability to lead cross-functional clinical teams and contribute to strategic development plans.
• Excellent written and verbal communication skills for both scientific and regulatory audiences.
• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.
• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).
• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.
• Prominent ability to work effectively and efficiently within cross-functional teams involved in the drug development process; prominent ability to efficiently integrate multiple perspectives into the CDP.
• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

Qualifications

• Required Skills, Experience and Education as outlined in the job description.