Medical Operations Lead

Job Title: Clinical Operations Expert

At our organization, we seek a highly skilled and experienced Clinical Operations Expert to join our team. The ideal candidate will have extensive experience in pharmaceutical or biotech industries with strong clinical practice background.

• The successful candidate will be responsible for providing medical support to Clinical Program Leader (CPL) leading the program, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables.

• May act as the medical monitor to support overall program safety reporting (e.g., Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team.

• May represent CPL at project team meetings (e.g. CTT) and may provide inputs to project strategy

• May represent CPL at Investigator teleconferences including dose escalation meetings and site initiation visits.

• Oversees the clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc.

• Leads the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation

• Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team

• Manages stakeholder engagements internally and externally

• Mentors and coaches junior TCO team members in India

• Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of SOPs and internal policies. Leads or assists with relevant trainings across TCO India

• Advocate continuous improvement of quality

• Ensure all activities of associates comply with company standards and local regulations

Requirements:

• MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required.

• Experience in hematology / oncology preferred

• At least 5 years of pharmaceutical/biotech industry experience

• At least 2 years of clinical practice experience in the hospital setting.

• Experience with oncology clinical trials

• Experience with early development clinical trials

• Knowledge of Good Clinical Practice (GCP).

• Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.

• Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects.

• Strategic thinking: ability to network with and influence key stakeholders, clear and logical presentation of complex strategic issues.

• Clear written and verbal expression of ideas, an active/proactive communicator.

• Well-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships.

• Used to working independently and in a team, being flexible and adapting in a changing environment.