- Clinical Trials
- Clinical Research
Working at Purdue
Accountable and responsible for clinical development, due-diligence, and implementation of oncology medical development plans on late-phase program assets and to contribute to developing earlier-phase oncology projects. In partnership with VP R&D and other functions, will develop and execute the long-term strategic plan for oncology therapeutics and continuously assess and determine the resources needed to support our oncology pipeline of products. Serves as oncology medical lead on global oncology asset development team including early and late stage programs. Responsible for designing and conducting oncology medical programs resulting in quality regulatory submissions. Responsible for the medical interface with regulatory authorities and commercial organization. Will oversee and contribute to other pipeline projects as required.
Has overall responsibility for creating and maintaining oncology clinical plans;provide strategic oncology related input across departments and their management.
Demonstrate an in-depth understanding of the needs of oncology patients and develop a focus on activities to meet those needs
Develop and execute clinical trial strategy and design working closely with Head of R&D, Corporate Business Development, Medical Affairs, Regulatory Affairs, and Commercial Development teams
Serves as in-house clinical expert in the therapeutic area of oncology, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
Provides expert opinion on the existing and emerging treatment options and unmet medical needs to inform key medical and business decisions.
Participate in review of promotional and medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
Leads the asset team to design, implement and conduct multi-phase development studies either in US/globally to support successful filing of regulatory submissions.
Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports
Responsible, in collaboration with leadership, finance, and clinical operations teams, for creating and adhering to the clinical development budget
Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSRs and clinical sections of regulatory submissions.
Authors protocols, protocol synopses, major protocol amendments and other clinical and regulatory documentation, with internal and external colleagues, to successfully achieve clinical validation of safety and efficacy of oncology assets
Represent company externally at scientific meetings, advisory boards, and through high impact presentations, publications, and other scientific communications.
Participate in the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs.
Education and Experience
MD, MD/PhD in life sciences or healthcare required with post graduate qualification and specialization in oncology.
Should have at least 10 years relevant experience in drug development in a biotech/ pharmaceutical company.
Experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; expert knowledge of scientific and clinical research methods and clinical study design.
Necessary Knowledge, Skills, and Abilities
Proven record of being a successful medical leader and a study clinician in a drug development atmosphere.
Experience managing drug development programs through US FDA approval.
Experience designing, implementing, and conducting clinical studies, to produce high-quality data. Proven ability to demonstrate results.
Demonstrated understanding of the clinical development and post-marketing environment for pharmaceuticals including post-marketing clinical studies and medical affairs strategic initiatives in Oncology.
Demonstrated ability to have designed and implemented programs and initiatives directed towards defined strategic objectives.
Excellent management, teamwork, communication and presentation skills and solid experience in developing strategic plans and oversight processes
Strong problem-solving skills and the ability to think and act strategically, anticipate road-blocks and map out next steps.
Capability to analyze and interpret complex data expertly, and clearly and succinctly communicate scientific results.
Excellent written, oral and presentation skills.
Demonstrated ability to build credible professional relations with Key Opinion Leaders.
Demonstrated high level of integrity, ethics and professionalism.
Positive and collaborative attitude that exemplifies ownership of business, teamwork with peers, and respect for the needs of our customers.
Supervisory Responsibilities (if Applicable)