Clinical Research Physician (TA Lead) - Neuroscience

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Clinical Research Physician (Therapy Lead) – Neuroscience

Purpose of the Role:

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Physician (CRP) is an integral member of the medical affairs, development and a business unit brand team for strategic planning in the support of launch and commercialization activities to meet patients’ needs and ultimately enhance the customers’ experience in interacting with the company.   The definition of “customer” here includes patients, providers (HCPs) and payers. The CRP may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase / Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases.  Specific activities include  developing or contributing to the global and/or regional clinical/medical  plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization.  In addition, with input from the Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase / Clinical Pharmacology, and Translational Medicine team(s).  
 

The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed.  The Clinical Research Physician is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.

Primary Responsibilities:

• To provide medical expertise in Neuroscience (Alzheimer’s Disease, Dementia & other conditions), specifically across the Lilly Neuroscience product portfolio, including affiliate, regional and global teams, contributing to medical strategies and brand commercialisation.
• Ensure detailed, current knowledge of the respective Molecule(s) data. And contribute to scientific and medical expertise to develop effective partnerships with relevant functions, including Pricing Reimbursement & Access (PRA), Clinical Operations, Corporate Affairs, Human Resources, Legal, Marketing, Medical Information, Global Product Safety and Training.
• To develop effective partnerships with clinicians, other key influencers and external groups.
• To provide visible leadership to other members of the Medical Department like Medical Affairs Professional (MAP) and Medical Science Liaisons (MSLs) and the broader India business To contribute Medical Education activities which may include business planning, approval and certification of materials and joint working with other Lilly functions.
• Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers)
• Actively address customer questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
• Contribute to the development of medical strategies to support brand commercialisation activities
• Contribute as a scientific and medical expert to activities and deliverables of the Access organisation, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
• Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.
• Offer scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
• Support training of sales representatives, and other medical representatives along with MAPs & MSLs

Provision of Medical Expertise

• Ensure detailed, up-to-date knowledge of the data surrounding the respective Molecule(s)
• Input into regulatory submissions and Health Technology Assessments (HTAs)
• Assist Medical Information and Global Product Safety in the affiliate as requested, including out of hours calls
• Drive and take accountability for the process and content of scientific publications
• Provide initial and ongoing disease, product and competitor training for all Lilly employees
• Provide presentation to groups of HCPs and others as determined by business needs
• Participate at an early stage in the production of materials with substantial or critical medical content (e.g. detail aids, clinical slide sets etc.)
• Attendance of relevant internal and external meetings
• Scientific Data Dissemination/Exchange

Compliance and Education

• Knowledge of compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Review and approve promotional and non-promotional materials in line with the local compliance guidelines.
• Drive the response to challenges from competitors,
• Comply with Good Pharmaceutical Medical Practice, Good Clinical Practices (GCP) and comply with all local laws
• Support the planning of symposia, advisory board and medical meetings
• Support medical information associates in preparation and review of medical letters and other medical information materials.
• Support training of local medical/non-medical personnel – Medical lead for internal training
• Prepare or review scientific information in response to customer questions or media requests
• Support data analysis and the development of slide sets
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.

Clinical Planning/Clinical Research/Trial Execution and Support
 

• Drive process of India Clinical Trial (CT) selection from the Global and Regional plan
• Input into the development of Global and Regional CT plans
• Implement, in consultation with the Clinical Operations lead, the Global / Regional CT plan with Quality Speed and Value
• Develop and implement a local CT plan. Participate in investigator interaction and site selection, start-ups, site issue resolution and Plan Do Review (PDR) meetings, trial initiation meetings along with MAPs wherever required

External Relations

• Identify and engage with Health Care Professionals (HCPs), Advocacy Groups, government and other professional bodies as determined by business needs
• Share and involve relevant HCPs compliantly in new developments / data surrounding the product
• Drive involvement of relevant HCPs at internal and external local, national and international meetings
• Drive appropriate involvement of relevant HCPs with publications and product communications

People Responsibilities

• Works closely with direct reports like Medical Affairs Professional (MAP) on performance management plans (objectives), development plans, and documentation of their expertise as and when there are direct reports to this position. Keeps these documents and plans up to date. Meets regularly with each direct report to coach, mentor, evaluate performance, evaluate training and development needs, and monitor career development goals. Maximizes each individual direct report’s career potential, maximizing the value to the organization 
• Actively participate in recruitment, diversity, and retention efforts, and hiring efforts as applicable
• Works closely with dotted line reports ie Medical Science Liaisons (MSLs) for enhancing their scientific knowledge on disease area and clinical trial data of the product, provide inputs for preparing field medical plans and its execution along with MSL Lead / Manager and MSLs. Participates in performance management discussions along with MSL Lead / Manager of the MSLs

Qualifications:

*Basic Requirements: Education and Experience

• Basic Medical Qualification (MBBS/MD)
• Full Medical Council registration or fulfilment of its eligibility criteria
• Therapeutic area clinical and/or industry expertise within Neuroscience domain (highly desirable)
• Evidence of strong teamwork and interpersonal skills
• Demonstrated ability to balance scientific priorities with business priorities
• Demonstration of initiative and motivation.
• Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
• Leadership capabilities to identify and develop new opportunities
• Excellent communication skills (presentation, written and verbal)
• Excellent self-management skills.
• Demonstrated ability to plan, organise, prioritise and adapt to changing needs
• Awareness of the role of medical doctors in a commercial setting
• Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English, verbal and written communication.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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