Job Description

Primary purpose of the role . The Clinical Research MD will play a key role at all stages of development for product programs from the drug discovery stage through clinical translation, early develop Primary purpose of the role . The Clinical Research MD will play a key role at all stages of development for product programs from the drug discovery stage through clinical translation, early development, and conception of overall clinical product development . The successful candidate will have oversight for ongoing and planned product trials within the Oncology and other therapeutic areas in the development portfolio . Lead the team in conceptualizing and planning trials, responsible for all scientific and medical aspects of trials. Develop appropriate documents including development of clinical study outline, study protocol and other study related documents. . Work with cross functional teams including regulatory, toxicology, CMC, clinical operations and internal and external stakeholders to develop scientific justification for pre-clinical assets to support IND ready package . Will lead the team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections. . Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures . Provides or oversees medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety assessment and monitoring . Ensures adherence of study conduct to the study protocol and applicable regulatory requirements and industry standards of Good Clinical Practice . Coordinates the collection and analysis of clinical data for internal analysis and review. . Will be part of a team responsible for defending the clinical trial and the clinical development program before regulatory authorities. . Supports the team in preparing for the Health Authority inspections and Internal System audits . Work across the discovery and development organization to provide medical consultation and vision to cross functional teams. Serves as a scientific and clinical resource within EDDC . Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff. . Assists in the clinical evaluation of business development opportunities. . Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings . Develops manuscripts for publication in peer-reviewed journals. . Act as senior EDDC representative towards EDDC and external partners . Accountable for implementation of all GCP requirements as well as other regulatory and A.STAR internal guidelines in all studies by ensuring adequate training of external staff. Experience/Professional requirement: . MD degree and board certification or equivalent years of clinical research experience preferably in Oncology . At least 8+ years required in the pharmaceutical industry with a proven success record in clinical research studies and trial design. Drug development experience either within biopharma industry, academic/research organizations early through late stage development, including the design and conduct of clinical studies . Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices. . Ability to think analytically and strategically to formulate, develop, and execute clinical plans. . Strong leadership skills with an ability to set vision, lead change, and mentor others. . Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving. . Excellent scientific written and oral communication skills. . Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results. . Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality. . Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (20-30% travel expected). . Will report to a more senior member of the clinical development team, who has direct responsibility for the overall research strategy and clinical and scientific development activities The above eligibility criteria are not exhaustive. A.STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.