- Gr nenthal
- $146,240.00 -146,240.00/year*
29 Bryant St
is an independent, family-owned organization headquartered in Aachen, Germany. To learn more about us, please visit .
Accountable for discovery and ultimate delivery of positive Proof-of-Concept studies for innovative pain assets by a) functional expertise and b) project leadership.
Professional and Educational Experience Accountable to provide expert functional input to create, advance and deliver a project/project idea from target idea to successful proof-of-concept clinical trial. Provides thought-leadership in EM/CS maximizing asset value. Contributes functional expertise and judgement to overall integrated asset plan, problem solving etc. Responsible for conduction and delivery of activities within agreed timeframe and area of expertise, in cooperation withother R&D related departments or external providers. Responsible to monitor and optimize performance and motivation of internal platforms and external providers to maximize output for the project. Good understanding of the external CRO/CMO provider landscape. Leveraging North America based external innovation (biotech, academia) by continuously scouting and evaluating partnering opportunities to fill into Gr nenthal s portfolio. Strong scientific and personal bonding with peers from other R&D related departments. Creates and maintains the Clinical Development Plan and strategy in alignment with the TPP; provides clinical input in the TPP, writing clinical PoM, PoP, Poc protocols. Ensures that strategy and trial designs are aligned with and appropriately challenged by internal and external stakeholders. Accountable for ensuring timely delivery and adequate quality of the clinical parts of project and submission documentation including responses documents as to ensure smooth internal decision-making / negotiations with health authorities and payors and a viable product label in line with the TPP. Understands the competitive landscape and provides both business intelligence and medical expertise in relationship to the indication and compound. Represents GRT medical expertise in meetings with regulatory authorities, payors/HTA bodies, advisory boards, external medical experts, etc. Designs and execute clinical trials by knowledgeably managing external vendors/CROs, accountable for the preparation of advanced protocol synopses, trial protocols and reports, investigator brochures. Consults with external medical experts and medical key opinion leaders in developing development programs and individual clinical trials. Accountable for primary publications (including clinical trial registries) of trials in alignment with the publication strategy and in agreement with regulatory requirements. Overall accountable while setting up and leading clinical project teams with members from Boston Innovation Hub and other R&D related departments, external providers, developing, shaping and owning the overall project science and the operational project plan, setting up agreement and monitoring of project budget and milestones/deliverables, ad-hoc problem solving as well as longer term learnings, all processes like screening cascade, data and physical material management etc., presentation to stakeholders, etc. M.D. with > 10 years of academic/pharmaceutical industry clinical experience as a clinical scientist in Neuroscience/Pain RnD with demonstrated expertise leading clinical projects. Strong demonstrated expertise in the field of experimental medicine/clinical science in pain RnD: planning and conduction of clinical PoM, PoP and PoC trials, modern designs (e.g. N=1, seamless trial, randomized withdrawal, etc.) Proven track record of successfully advancing clinical candidates (> 2) in the area of Neuroscience/Pain up to PoC, strong record of publishing and presenting scientific primary results. Expertise in Clinical Pharmacology, Pharmaceutical Medicine, and Pharmacotherapy. Familiarity to successfully work and deliver projects within highly outsourced and matricized environments across diverse geographies and working cultures. Ph.D. with > 10 years of pharmaceutical industry RnD experience as a senior scientist and > 5 years of experience as project leader in Neuroscience/Pain RnD (Target Identification to PoC). Strong demonstrated functional area expertise chemistry and preclinical development relevant to Neuroscience/Pain (> 10 years). Proven track record of successfully delivering high quality clinical candidates (> 2) in the area of Neuroscience/Pain, strong record of publishing and presenting scientific primary results. Familiarity to successfully work and deliver projects within highly outsourced and matricized environments across diverse geographies and working cultures. Familiarity with more than one of the following therapeutic modalities preferred: small and large molecules, cell and gene therapy. Truth seeking and delivery focused, driven/passionate scientists with strong focus on creating value, problem solving and making things happen: role model. Strong at building, driving, leading and delivering within collaborative and high performing project teams in virtualized settings and with diverse geography and working cultures. Clinical Judgment Experience - including a demonstrated proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOP(s) and regulatory standards. Able to work in a highly outsourced model (e.g. good at planning, flexible, quick acting, foresees problems, good TC/communication skills etc.). Fluent business English language skills. Up to 30% of national and international travel will be required for this role. Challenge the status quo in constructive manner, trying and executing on new things and taking smart risks to create and deliver value for the patients and Gr nenthal. Strong matrix leadership skills to lead, motivate and influence non-hierarchical, international, multi-functional teams of highly skilled project members and internal as well as external platform scientists. Solid and well-established networking ability in a cross-cultural internal and external environment. Can-do person, problem solvers who like to make their hands dirty driving projects forward. Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization are required. Pragmatic and non-territorial approach to value generation for Gr nenthal Innovation.
GRT Therapeutics is an Equal Opportunity Employer that is committed to inclusion and diversity. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or Veteran status, disability, or any other legally protected status.
Associated topics: dietetic, disease, histology, industrial hygienist, kinesiology, nutrition, pharmaceutical, physiologist, therapy, toxicologist
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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