Medical Director, Medical Affairs Job Description

Medical Director, Medical Affairs Job Description

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Medical director, medical affairs provides regulatory guidance on projects including regulatory strategy, requirements for clinical studies and marketing approval in domestic and international markets, strategic development plans, and Health Authority interactions.

Medical Director, Medical Affairs Duties & Responsibilities

To write an effective medical director, medical affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included medical director, medical affairs job description templates that you can modify and use.

Sample responsibilities for this position include:

In anticipation of product launch, the Medical Director will ensure that he/she and his/her team provide medical support, education and guidance to commercial, marketing and sales teams
Develop and support key clinical and medical affairs strategies in conjunction with commercial counterparts
Execute on life cycle management plan for Dupilumab
Ensure a patient-centric approach to development of medical strategy both for product and device development possible services which can enhance the value proposition of the product
Support the development of Investigator Sponsored studies
Provide Medical Affairs support to the review of requests for grants and sponsorships
Provide ongoing support for company sponsored trials in alignment with Clinical Development strategy
Assure medical/scientific integrity of clinical development programs and their deliverables
Global Medical ‘point of contact’ for the designated medicine(s) within the Pain franchise
Accountable for the development and execution of the Global Medical Affairs plan

Medical Director, Medical Affairs Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Medical 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 Medical Director, Medical Affairs

Typically a job would require a certain level of education.

Employers hiring for the medical director, medical affairs job most commonly would prefer for their future employee to have a relevant degree such as Doctorate and Master's Degree in Medical, Medicine, Science, Education, Life Sciences, Medical School, Pharmacy, Oncology, Graduate, Sciences

Skills for Medical Director, Medical Affairs

Desired skills for medical director, medical affairs include:

Clinical trial methodology
Regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
Pharmaceutical marketplace
Regulatory guidance regarding marketing/sales promotional materials
Commercial
Pharmaceutical product development
Regulatory
Regulatory and compliance requirements
Allergy
Disease areas understanding of patient and physician interactions and clinical decision making and impact

Desired experience for medical director, medical affairs includes:

Intermediate to advanced proficiency level in applied biostatistical methodology with emphasis on pharmaceuticals is required
Demonstrated experience as an individual contributor is required while managing workflow in a cross-functional matrix organization is preferred
Written skills as evidenced by publication and journal articles is preferred
Possesses the presence and credibility to establish and maintain positive and productive relationships with a variety of audience and stakeholders
Ability to travel across assigned area
Advanced degree (PharmD, MD, PhD) with a minimum of 3 years’ experience in a role within Medical Affairs or Clinical Research

Medical Director, Medical Affairs Examples

1

Medical Director, Medical Affairs Job Description

Job Description Example
Our company is hiring for a medical director, medical affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for medical director, medical affairs
  • Responsible for medical interpretation of data (clinical trials, registries, published literature, ) for in-development and marketed compounds
  • Possess understanding of government and industry guidelines, regulations, laws, , for appropriate scientific/medical exchange and communication with customers
  • Serving on the product development committee to ensure that clinical development activities are consistent with the medical vision for Lexicon diabetes products
  • Developing and managing appropriate research programs, including investigator-initiated studies, collaborative studies, expanded access programs, and non-registrational company-sponsored studies
  • Establishing and maintaining relationships with leading physicians in diabetes as part of medical and scientific communication
  • Contributes to the development of and leads the execution of the Medical Education generation in line with TA plan
  • Support teams with subject matter expertise
  • Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IISs
  • Provides scientific/medical education to investigators, clinical monitors, and Global Project Team members related to Rheumatology
  • Support the Global Pharmacovigilance Dept
Qualifications for medical director, medical affairs
  • In-depth working knowledge of statistical software such as SAS, R, or related software is required
  • 5+ years in industry setting
  • Well-organized, with demonstrated ability to work effectively in a highly matrixed and cross-functional environment
  • Readiness to work in a global matrix type environment
  • The ability and flexibility to have significant global travel (approx
  • At least 2-5 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications
2

Medical Director, Medical Affairs Job Description

Job Description Example
Our company is hiring for a medical director, medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical director, medical affairs
  • Identify and evaluate new trends and therapeutic area opportunities that could lead to competitive advantages in cooperation with R&D and the regional commercial organizations
  • Define and implement global publication strategy in collaboration with the responsible commercial and R&D counterparts
  • Research and provide reports on the clinical data in support of diverse corporate initiatives including regular journal tracking reports and summaries of key publications, regulatory submissions (including Clinical Evidence Reports, IDEs and 510ks)
  • Develop and maintain relationships with academic institutions and key opinion leaders for the purposes of business and research collaboration
  • Participate in the development of marketing material for use in the U.S. clinical market
  • Support sales and marketing through presentations at customer sites, congresses and symposia
  • Develop white papers and evidence-based technical documents advancing patient care in the relevant fields of practice for this role
  • In collaboration with US Marketing, manage the BDB relationship with strategic key opinion leaders (KOLs)
  • Keep abreast of emerging technology in the diagnosis and management of hematological and immune disease
  • Interact directly with customers with regard to product performance queries, discrepant results
Qualifications for medical director, medical affairs
  • Experience working in Medical Affairs Statistics is preferred
  • MD or Pharm.D
  • 10+ years of progressive experience in the pharmaceutical or medical device industry required
  • Strong focus on personal accountability and ownership – constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence
  • BA/BS is required, ideally in science or medical field
  • Minimum 2-3 years in a strategic business role
3

Medical Director, Medical Affairs Job Description

Job Description Example
Our growing company is looking for a medical 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 medical director, medical affairs
  • Be responsible for pre-launch medical activities of new indications for this product including Therapeutic Area global advisory boards, medical symposia and congress activities, in collaboration with functional leads of regional activity in these areas
  • The Global Medical Affairs Medical Director will be an active member of the core product CDTs and will lead a global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one "unified" voice on the CDT
  • The GMAF Medical Director will be responsible for review and approval of proposed evidence generation activities within Medical Affairs for [TA] products
  • Subject matter appropriateness (medical/scientific) of external interactions (eg
  • Direct reporting line leadership of USML, Sr
  • Ensures appropriate medical leadership of compliance
  • Ensure that staff and vendors are adequately trained to perform their functions and are following company SOPs and ICH guidelines
  • Create objectives that are in-line with corporate and global MAF goals, are measurable
  • Manage performance of direct reports – including recruiting, hiring and retention
  • Understanding of country Medical Affairs strategy and tactics, competitors, and Neuroscience and Vaccines Franchise priorities
Qualifications for medical director, medical affairs
  • Progressively responsible management experience
  • Must have effective communication and great interpersonal skills
  • Advanced education (e.g., PhD, PharmD, PA, NP) highly preferred
  • Board Certification is a plus
  • Develop and continuously maintain the highest scientific and medical expertise with all diseases and products within the Metabolic Franchise and be acknowledged internally and externally as an expert in these areas
  • Maintain a high level of knowledge of and appropriately implement current local pharmaceutical regulation in conjunction with Pharmaceutical Affairs
4

Medical Director, Medical Affairs Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of medical director, medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical director, medical affairs
  • Keeps current on regulatory changes and adapts RMD resources to meet market needs
  • Manages global key opinion leaders consistent with MSA strategies and initiatives
  • Networks across business areas to establish and benchmark “best practices” in Medical Affairs
  • Interacts with external resources on matters of significance to the Company on areas related to subject matter expertise
  • Aid in the design, development, management, analysis, interpretation, writing, presentation, and publication of clinical studies
  • Provide study support ranging from protocol development to submission and completion for post-marketing studies
  • Provide clinical support for activities related to health economics and patient related outcomes market access/payers strategies
  • Develop publication strategies scientific and academic network
  • Develop topics and compile data for educational presentations and slide kits
  • Contribute scientific, clinical, and experiential insights to Investigator-Initiated Trial, Medical Education Grant, and Contributions review processes
Qualifications for medical director, medical affairs
  • Perform data listings review and assist in study report generation, as needed
  • Periodically review all study related patient safety data
  • Computer literate with MS PPT and Word software CRM software
  • Matrix leadership skills of cross-functional teams
  • Demonstrated customer focus orientation & credibility with physicians, researchers and KOLs
  • 5 + years industry / business experience with a minimum of 2 years’ experience in a relevant area for this function
5

Medical Director, Medical Affairs Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of medical director, medical affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for medical director, medical affairs
  • Working closely with the relevant Therapeutic Area Director/Project Manager, develop and implement European medical initiatives for relevant therapeutic areas, ensuring alignment with commercial strategies
  • Ensures that all EU Medical Affairs activities within the assigned franchise areas fully comply with all applicable legal and self-regulatory requirements
  • Oversees compliant and cost effective development and use of clinical evidence in support of product development, product approvals/registrations, product positioning & claims, coverage/reimbursement, and post-marketing surveillance
  • Ensures that effective leadership and appropriate resources are utilized in order to meet objectives and assures technical excellence of all staff within the medical affairs functions
  • Drives the development and maintenance of corporate standard operating procedures to allow adherence to compliance requirements, setting a framework for results oriented approach of medical affairs activities in partnership with regional and divisional stakeholders
  • Identifies with and actively communicates/applies company values on a consistent basis
  • Works in a goal/objective oriented manner within formalized process to plan and execute annual goals in alignment with the corporate annual goals and core business strategy
  • Takes leadership role and/or participates as active member on cross functional teams
  • Accountable for creating and managing resources within annual Medical Brand Budgets, and expenses
  • Elaborate on the current standard of care (SOC) for the target diseases by developing and executing Global Medical Research (GMR) strategies (IST program, registry, other phase IV when needed) performing opportunity and gap analyses
Qualifications for medical director, medical affairs
  • National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment
  • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent
  • Has good knowledge of TA/disease/product and is able to operate across several products within TA
  • Experience in successfully leading cross-regional and cross-functional matrix teams either within Medical Affairs or clinical development
  • A minimum of 5 years of experience in medical affairs for a pharmaceutical company
  • Familiarity with the role of CRO, including experience with CRO management

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