Medical Director or Clinical Research Director
Company: Sanofi Group
Posted on: May 27, 2023
Job summary and key strategic intent
The Medical Director manages the clinical development of drug candidates, medical monitoring of trials, including first in human phase I-II studies primarily in oncology. The Medical Director will have a solid understanding of all phases of early pharmaceutical drug product development, including clinical trial management, IND and CTA submissions, medical monitoring, GCP principles, and will have experience in collaboration with Clinical Science, Clinical Operations, Research and Clinical Pharmacology, Regulatory Affairs and other key stakeholders.
The role requires strong subject matter expertise and/or ability to independently research the area of study, and is a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation and ability to operate at a "hands on" level and leads trial conduct with ease and authenticity.
Serve as Medical lead on one or more early preclinical/clinical molecules within the Amunix pipeline from and able to apply clinical relevance and translation from preclinical data as projects move from Phase I through proof of concept.
Serve as Medical lead on individual clinical trials in partner with Clinical Science, Clinical Operations, Drug Safety and other key stakeholders
Contribute to strategic and scientific discussions on related projects and technologies within the Clinical Development team.
Key individual duties, responsibilities
Contribute to clinical development planning and clinical strategy
Work with academic leaders/advisers to develop clinical strategy
Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable
Develop protocols to execute clinical development strategies
Clinical deliverables may include clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
Review all key documentation such as IND/CTA, health authority communications and other documents (DUSR, INDAR, DRMP, RMP, etc), protocols and amendments
Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) and supports all other Regulatory activities and NDA related questions
Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock, performs data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)
Drives execution of the section of the clinical program in partnership with other line functions (regulatory, clin ops)
Act as study medical monitor ensuring overall safety of the molecule for the assigned section, and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
Consistently complies with, and ensures the compliance from direct reports, of all governing laws, regulations, Amunix Standard Operating Procedures (SOPs) and other guidelines
Keeps abreast of the highest standards and levels of scientific and clinical knowledge in relevant therapeutic and disease area(s).
Review all data generated across the program to update strategy and risk assessment
Regular review of competitive intelligence to update risk, differentiation and valuation of program
Collaborates with Sanofi and external partners, regulators, and diverse internal stakeholders and collaborators
Other duties commensurate with position as assigned
Ability to travel required
Skills, competencies required
Experience with pharmaceutical product development collectively through clinical science or clinical trial conduct
Expertise in clinical development and methodology of clinical studies and GCP principles
Ability to adapt and learn quickly in new areas of research, clinical development, and have resourcefulness to independently gather relevant information
Independent creative thinking related to overcoming hurdles and problems.
Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with investigators, key regulatory agencies
Demonstrated capability to challenge decision and status quo with a risk-management approach
International/ intercultural working skills
Education and background
M.D. degree with a minimum of 5 years industry experience, or comparable experience in academia
Demonstrated ability to independently evaluate, interpret and present complex scientific data
Demonstrated ability to critically evaluate complex drug development programs
Demonstrated ability to work within a multi-disciplinary team of peers and outside experts
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
The salary range for this positio n is $ 135,515.63 - 180,687.50 to $ 225,859.38 . All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Job summary and key strategic intent
Keywords: Sanofi Group, Indianapolis , Medical Director or Clinical Research Director, Executive , Indianapolis, Indiana
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