Sr. Director (Medical) Oral Therapies

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.* Understand and anticipate the scientific information needs of all local customers (payers, patients, health care providers)* Actively address customer (payer, patient and health care providers) 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 commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes/Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.* Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.* Support business-to-business and business-to-government activities as medical expert.* Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.* By offering 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.* Become familiar with market archetypes and potential influence on the medical interventions for the product.* Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become patient advocate, as well as a medical expert.* Understand and apply knowledge of customer insights to all customer-related activities.* Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).* Knowledge of and 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.* Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.* Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.* Support medical information associates in preparation and review of medical letters and other medical information materials.* Support training of local medical personnel, including medical and/or outcome liaisons and health outcomes staff.* Prepare or review scientific information in response to customer questions or media requests.* Provide follow-up to information requested by health care professionals as per global SOPs.* Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).* Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.* Develop and maintain appropriate collaborations and relationships with relevant professional societies.* Support the design of customer research as medical expert.* Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).* Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.* Participate in reporting of clinical trial data in Clinical Trial Registry activities, if necessary.* Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Experience, and PRA teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers (for example, through global medical planning processes), if needed.* Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.* Represent the clinical needs of Mexico to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.* Review and approve local informed consent documents and risk profiles to ensure appropriate communication of risk to study subjects.* Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).* Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.* Participate in investigator identification and selection, in conjunction with clinical teams.* Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.* Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.* Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.* Review IIT proposals and publications.* Understand and actively address the scientific information needs of all investigators and personnel.* Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.* Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label.* Provide medical expertise to regulatory scientists.* Support/ assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.* Participate in advisory committees.* Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).* Needs deep knowledge of molecule and existing development plan* Will need to be well versed on trial(s) results and conclusions, thus will need to work closely with submission teams* Ideally would be partnered with an affiliate headcount sitting within the team who can go back to the region to establish the medical brand team prior to launch - seed the region with experience* Thought leader engagement and relationships will be essential - shared and coordinated responsibility between Global Product Team (GPT) and regions and functions* Works cross-functionally and cross geography* Need strong scientific expertise and people skills* Must have an understanding of the endocrinology and other specialties related to T2D customers, diabetes business, with strong planning and execution skills* Leading medical affairs pre- peri- and post launch activities* Leverage deep product knowledge and educate the network#J-18808-Ljbffr

Creado: Jue, 01 de Ene de 1970