Manager/ Senior Manager - Clinical Development lead

Manager/ Senior Manager - Clinical development lead

• MBBS, MD in clinical pharmacology or relevant discipline over 2-3 years of experience in supporting & managing NCE/NBE clinical development programs.
• Clinical development experience (in the pharmaceutical or CRO environment) related to the design and/or conduct of NCE/NBE clinical studies in one or more areas of oncology, immune-inflammation, immune-oncology.
• Significant experience, both as a clinical development leader and as a medical monitor, in the IND, Ph1 & Ph2/PoC settings in the relevant therapeutic areas is of paramount importance.
• Clinical development experience in Cell & Gene Therapy desired but not required
• Ability to integrate translational research, clinical pharmacology & pharmacokinetic approaches to enable early clinical development is of critical value.
• Strong understanding of relevant regulatory health authority expectations and regulations as it relates to early clinical development and experience of having interfaced with such agencies.
• Prior track record of having authored clinical development plans, protocols, investigator brochures, regulatory submissions etc.
• Significant experience in clinical trial budgeting, vendor/CRO ID, contracting and project management.
• Proven ability to apply broad multi-disciplinary expertise to problems to arrive at innovative strategies and solutions to support clinical development objectives.
• Demonstrated management and leadership skills in a matrix environment; Can influence decision making with internal stakeholders, customers and collaborators.
• Participate as the clinical program leader on project teams. Develop expertise on specific disease areas of relevance to the program, current clinical practice insights, standard-of-care treatment protocols, diagnosis & prescription patterns across geographies etc.
• Be the clinical lead for Cell & Gene Therapy products
• Integrate clinical expertise and market intelligence data towards indication selection and clinical development planning for the assigned programs.
• Develop detailed clinical development plans complete with proposed indication strategy, trial design, regulatory roadmap etc., in collaboration with regulatory, preclinical and CMC teams.
• Work with the project leader and the preclinical, DMPK, toxicology, CMC and translational biology team members to draft & integrate relevant parts of the IND, IMPD, Target Product Profile etc.
• Responsible for drafting & finalizing submission-quality versions of clinical protocols, investigators brochures, response to queries and all associated clinical study related submissions for the assigned programs in collaboration with the regulatory affairs & project team members.
• Assess clinical trial capabilities of various vendors across geographies, work with QA & logistics team in identifying optimal clinical trial vendors (trial conduct, insurance, trial monitoring, DSMB, data mgt, reporting, analytical etc) and support the contracting process.
• Develop & forecast clinical trial budgets, track costs and project manage smooth execution of the clinical program within allocation.
• Coordinate with the various internal & external team members to support the clinical trial planning, logistics, supply chain, conduct, monitoring, analyses, reporting & closeout activities.
• Participate in the go/no-go decision-making processes related to the dose escalation, safety monitoring, adverse event reporting etc. Coordinate with various internal & external stakeholders to facilitate decision-making.
• Identify relevant clinical experts who can be co-opted as consultants or as advisory board members to provide expert feedback on indication selection, development planning, clinical positioning etc.