Director, Medical Affairs Job Description
Director, medical affairs
provides medical input to investigator’s brochure, clinical trial protocols, clinical trial reports and briefing documents for regulatory authorities Monitor ongoing trials.
Director, Medical Affairs Duties & Responsibilities
To write an effective director, medical affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included director, medical affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Review of draft IR protocols, reports and manuscripts management of regional IR processes
Development, execution and maintenance of MSL SOP’s
This role requires close interdepartmental collaboration and alignment of goals and objectives of Field Medical Affairs, with our Commercial counterparts our key strategic partners
Present at training courses, sales conferences, regional and international meetings, to develop high level of medical knowledge within the region
Be expected to travel 30% of the time
Provides expert opinion on the current trends in the pathophysiology, diagnosis, existing and emerging treatment options unmet medical needs in the therapeutic area to inform key medical and business decisions
Participate in and support clinical and medical affairs strategies in conjunction with commercial counterparts
Primary focus in IBD will initially be on ozanimod
Participate in scientific review of submitted Investigator Initiated Trials and related medical affairs activities
Establish and maintain strong relationships with experts in the Dermatology field, academics and professionals and/or patient associations
Director, Medical Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Medical Affairs
List any licenses or certifications required by the position: MD, CMPP, ABPI, M.D, FEMA, MV, DMOS, ASQ, BU, PMP
Education for Director, Medical Affairs
Typically a job would require a certain level of education.
Employers hiring for the director, medical affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Doctorate Degree in Medical, Medicine, Science, Oncology, Life Sciences, Education, Pharmacy, Medical School, Sciences, Graduate
Skills for Director, Medical Affairs
Desired skills for director, medical affairs include:
Clinical trial methodology
Microsoft Office Suite
Regulatory
Regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
Processes
Development of appropriate medical materials and supportive documents and provision of medical expertise as
OPDP promotional regulations
Scientific information
Therapy area
Clinical trial design
Desired experience for director, medical affairs includes:
Ability to successfully multi-task and work independently, under minimal supervision
This position will be located in Titusville, NJ or Raritan, NJ and will require up to 10% travelBiostatistics
1 year people management experience required, this may include management in a matrix environment
Expert understanding and experience in medical affairs and clinical research in the pharmaceutical industry
Able to lead, motivate and inspire a team of experienced professionals
Strategic thinker, with a reputation for productively challenging others to consider other courses of action
Director, Medical Affairs Examples
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Director, Medical Affairs Job Description
Job Description Example
Our innovative and growing company is looking for a director, medical affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for director, medical affairs
- Working with Global and regional Marketing, develop an annual evidence generation roadmap, including gap assessments and identifying and securing resources required to successfully complete the evidence requirements for a particular product
- Partner with external experts in order to optimize clinical study design and develop ongoing relationships with KOL investigators in the Diabetes therapeutic arena
- Partner with corporate statistics and Corporate Clinical Development teams to ensure optimal study design, protocol and conduct
- Leads the development of a comprehensive diabetes clinical investigation database within Advanced Diabetes care, aligned to evidence generation needs and roadmaps
- Leads Investigator Initiated Study strategy and manages this process within Advanced Diabetes Care
- Define specific medical programs and activities
- As a subject matter expert provide day-to-day clinical and medical guidance while working closely on joint projects with other members of the Medical Affairs team and other departments within Jazz
- Developing strategies and tactics to support brand needs
- Providing medical expertise to support the development of cross-functional strategies and tactics in support of the brand plan for diabetes compounds
- Planning and implementing advisory board meetings to gather guidance on clinical development, medical strategies, educational activities, and value propositions for Lexicon diabetes products
Qualifications for director, medical affairs
- A Doctoral Degree in Medicine and/or a PhD in health sciences
- Demonstrated experience with providing advanced data insights expert knowledge of analysis tools
- Proficient in Microsoft Excel, Qlikview and other common analytic tools, especially data collection and visualization techniques that can be readily updated frequently ad hoc
- Previous experience with Cedegim EI, iEI, Siebel systems preferred
- Previous management / supervisory / consulting experience preferred
- Basic knowledge of ICH-GCP
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Director, Medical Affairs Job Description
Job Description Example
Our growing company is looking for a director, medical affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for director, medical affairs
- Agreement-budget negotiation and completion with the site
- Monitoring at the site, as defined in the protocol/agreement
- Issuance of payments
- Filing/Saving of study related documents in the varied systems
- The Associate Director will be responsible to identify any gap, issues, concerns related to the above-listed projects and will contribute to finding the best solutions
- Other responsibilities may be added based on the Medical Affairs needs and the Associate Director’s field of expertise
- Participate in strategic planning at the clinical platform level
- Provide critical clinical input to the product development teams working on new applications
- Provide clinical guidance, support and education to customers prospective customers
- Lead and implement multicolor flow educational programs for both external and internal customers
Qualifications for director, medical affairs
- Experience in the area of Infectious Diseases, Vaccine, and/or Oncology clinical research is preferred
- 12 + years of experience in medical affairs or medical practice is preferred
- Experience in the area of Infectious Diseases, Vaccine, Cardiovascular & Metabolics, Neuroscience, and/or Oncology clinical research is preferred
- 5 plus years of experience in industry and/or academic research experience
- Medical degree and/or PhD with specific background in the role relevant therapeutic area (Heart Failure)
- Experience with developing and measuring performance outcomes
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Director, Medical Affairs Job Description
Job Description Example
Our company is growing rapidly and is looking for a director, medical affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for director, medical affairs
- Partner very closely with commercial counterparts, CRD, translational regulatory, project leadership and market access
- Responsible for developing and managing global publication plans and scientific information tools for affiliates on Microbiology products
- Establishes and support the development of Medical Affairs processes which are aligned with the global medical activities across the division
- Provide subject matter expertise and function as US medical representative with internal stakeholders across multiple functional areas including marketing and sales, health economics and outcomes research, MSLs, and medical information
- Directly supervise and monitor trial conducts work closely with other Medical Affairs medical monitor physicians to assure consistency of conduct across trials
- Be responsible for medical monitoring/reporting and company safety officer activities
- Identify opportunities for appropriate, relevant generation or communication of scientific data
- Implement Scientific Review process for IITs, creating externally communicated scientific research priorities
- Develop global medical affairs strategy and plan for the compound based on prioritized regional needs
- Partner closely with the Senior Director or Vice President of Global Medical Affairs and other GMAF Leaders to ensure one franchise strategy
Qualifications for director, medical affairs
- Advanced science and/ or MBA strongly
- Experience in Oncology medical program planning
- Minimum of Bachelors’ degree required, Advanced degree (Pharm
- Expert research and analysis skills required including
- Able to guide project teams in multiple technical areas (programming, modeling, literature analysis)
- Ability to develop an operating budget to monitor expenditures and project deliverables
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Director, Medical Affairs Job Description
Job Description Example
Our company is looking to fill the role of director, medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, medical affairs
- Attendance at key (molecular) diagnostics scientific congresses to provide scientific support congress feedback for the IBT
- Management of scientific symposia and educational events at key internal meetings and international scientific congresses, including managing speakers
- Participates in product strategy development with international product managers (including market research of new concepts, "reality checks")
- Responsible for providing scientific and clinical support for affiliates
- Review publications for scientific and medical content
- Responsible for managing all non-registrational clinical trials
- Responsible for the implementation of global study support strategies and initiatives and facilitates open channels of communications across divisions to align these scientific strategies
- Oversees and is responsible for the design, execution, and reporting of non-registrational clinical trials
- Develops and is accountable for managing the Medical Affairs budget
- Responsible for the RMD investigator initiated study program
Qualifications for director, medical affairs
- Drive the identification, development and alignment with Key Opinion Leaders, other important customers and stakeholders, including professional organizations
- Define and communicate the local Medical Affairs resources required to optimally achieve the local objectives
- Conduct, or participate in training programs for the commercial teams and other functions, ensuring to provide medical leadership, education in line with local and global strategy and prepare staff to handle interactions with customers
- Develop and execute a local publication plan, aligned with local and Global strategy to ensure widespread data dissemination and local data generation, including congress abstracts, publications, and case studies
- Provide appropriate and timely medical affairs support, including time spent in the field, to all commercial team efforts, in particular to patient identification, increasing the urgency to treat, access to funding and appropriate product utilization, all to maximize patient outcomes
- Serve as the primary medical contact with collaborators and opinion leaders
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Director, Medical Affairs Job Description
Job Description Example
Our growing company is hiring for a director, medical affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for director, medical affairs
- Support R&D organization (e.g., Phase IV, due diligence)
- Developing, maintaining and executing training programs, on boarding through advanced training, for MSLs and other teams in Medical Affairs
- Collaborating with cross functional teams across Kite to provide disease state, product and therapeutic training as required
- Managing vendors and performing project management function during development of training content and execution of training initiatives
- Planning, designing and leading the execution of training offerings at internal meetings and conferences
- Supporting the maintenance of the learning management system and incorporation of distance based learning applications
- Participation in Medical Affairs department meetings, including attendance at off site meetings as required
- Representation of Medical Affairs internally to senior management and cross functional partners and externally to healthcare providers as needed
- Executes the yearly strategic and operational objectives for medical affairs
- Sets a framework for results oriented approach of medical affairs activities in partnership with regional and divisional stakeholders, including the Global Franchise Leads and business presidents
Qualifications for director, medical affairs
- Enable and drive change – ability to influence/lead to deliver results
- Flexible thinking – ability to analyze external environment and translate to strategy
- Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice
- Must possess a comprehensive clinical knowledge of Oncology keen understanding of strategic clinical development and principles of study design
- Strong people management and team leadership skills, listening and coaching skills
- Medical Doctorate (M.D.) degree or equivalent (D.O