Medical Director, Medical Affairs Resume Sample
Walter Zieme
45169 Hackett Divide,
Dallas,
TX
+1 (555) 973 4787
Work Experience
Medical Director, Medical Affairs
01/2017
-
PRESENT
San Francisco, CA
- Participate in appropriate cross-functional and cross-company teams to represent Medical Affairs, including teams related to Akebia’s external partnerships
- Develop and maintain relationships with international thought leaders through Advisory Boards, Professional Associations and Meetings to achieve company’s scientific objectives
- Reports to the Medical Director (leading the product's strategy), Oncology Medical Affairs, Americas
- Interacts with key external experts industry thought leaders and collaboration partners
- Act as primary contact for investigators interested in developing and performing studies with the company’s commercially available assays in oncology and urology
- Provide US-focused medical input to and review of US commercial plans and global strategic documents
- Foster and cultivate relationships with US Opinion Leaders and medical/scientific societies
- Support the development and execution of product lifecycle management plan in conjunction with US Brand Team and Global Development
Medical Director Medical Affairs
08/2014
-
10/2016
Houston, TX
- Design and execute phase 4 clinical trials and observational research to support clinical and commercial activities in partnership with Development Operations, Center for Observational Research and Global Health Economics
- Provide medical input and support for publications, training, RML support, congress activities and other scientific affairs activities
- Provide medical input, review and participate in approval of materials used by scientific affairs or the US commercial organization
- Provide medical content expertise for documents and participate in meetings in support of regulatory, safety, health economic and reimbursement interactions in the US
- Lead execution of medical Advisory Board Meetings
- Review US Non-Amgen Sponsored Clinical Research (NASCR) proposals
- Supports the GMAL in gathering medical insights from the Franchise LOCs and external takeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan
- Strong knowledge of hematology, and in particular, strong depth of knowledge in leukemias and lymphomas
- Working knowledge of biostatistics and pharmacokinetics
Medical Director, Medical Affairs, Neurology
07/2009
-
02/2014
San Francisco, CA
- Possess an understanding of applicable US and EU drug development regulations and GCP regulations
- Pharmaceutical clinical research experience
- Work collaboratively in a team-based environment with minimal supervision
- Detail-oriented, with excellent planning, time management and organizational skills, and the ability to work independently while organizing multiple tasks and meeting aggressive deadlines
- Proven ability to develop internal relationships, as well as external relationships with opinion leaders and industry experts
- Engage in positive dialogues, influence outcomes and resolve conflict in a constructive manner
- Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
Education
Robert Morris University - Peoria Campus
2004 - 2009
Science's Degree in Management
Professional Skills
- Strong analytical skills, comfort managing through ambiguity
- Experience building and managing strong working relationships between contracting organizations, site industry sponsors, and academic partners
- Sound computer skills including Microsoft Word and PowerPoint
- Sound computer skills including Microsoft Word, and PowerPoint
- Strong leadership presence and the ability to work effectively with other clinical and scientific leaders
- Demonstrated experience in early and late clinical development
- Industry experience, with substantive experience in key aspects of a product (pre-approval or in-line) Medical program
How to write Medical Director, Medical Affairs Resume
Medical Director, Medical Affairs role is responsible for clinical, research, microsoft, leadership, powerpoint, manufacturing, retail, training, integration, oncology.
To write great resume for medical director, medical affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Medical Director, Medical Affairs Resume
The section contact information is important in your medical director, medical affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Medical Director, Medical Affairs Resume
The section work experience is an essential part of your medical director, medical affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous medical director, medical affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular medical director, medical affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Medical Director, Medical Affairs resume experience can include:
- Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development. Identified training needs
- Develops, reviews and follows up on clinical studies and medical projects initiated within the relevant therapeutic area (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.) at the regional/local level
- Providing relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives
- Experience in the biotech/ pharmaceutical industry and/or clinical practice/academic setting in the field of multiple sclerosis
- Member in good standing of Hackensack University Medical Center's Medical staff
- Experience working within Medical Affairs for a biotech/pharma company highly desirable
Education on a Medical Director, Medical Affairs Resume
Make sure to make education a priority on your medical director, medical affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your medical director, medical affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Medical Director, Medical Affairs Resume
When listing skills on your medical director, medical affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical medical director, medical affairs skills:
- Effectively influence both internal and external stakeholders,
- Global perspective and mindset; ability to work effectively with colleagues from myriad cultures, backgrounds and geographies
- Oncology medical affairs experience in pharma and/or biotech
- Effective management of KOL and advisory boards
- Proven ability to successfully partner with the Development and Commercial teams
- Demonstrated passion for helping patients with cancer and for the science of oncology
List of Typical Experience For a Medical Director, Medical Affairs Resume
1
Experience For Medical Director Medical Affairs Resume
- Strong project management skills and ability to work effectively with cross functional teams
- Provide appropriate and timely medical affairs support to key commercial and reimbursement activities aligned with strategic priorities
- Collaborate with risk management/performance improvement/legal departments toward improved patient safety, clinical performance and evidence-based initiatives
- Attend scientific meetings and foster and develop strong relationships with health care leaders and investigators in rheumatology
- Help establish and mange effective relationships with Key Opinion Leaders so as to
- OR PhD or PharmD with 5-10 years experience in oncology within the pharmaceutical industry
- Orphan diseases knowledge/experience
- Support the US initiative for MS thought leader engagement/relationship-building
2
Experience For Associate Medical Director, Medical Affairs Resume
- Ensure timely Country Publication Planning and Communication activities in supportive of Global Medical Affairs strategy
- Open, engaging and transparent.Also comfortable with conflict and able to push back when needed
- Be a “medical voice” and “scientific mind” on the cross-functional Brand Team
- Provide clinical and scientific review of all promotional materials as a key member of the cross-functional MLPC team
- Support the development and execution of key elements of the medical launch plan, including publications, presentations, training, CME, and life-cycle management studies
3
Experience For Medical Director, Medical Affairs, Neurology Resume
- Provide medical support to promotional and legal review committees as needed
- Exemplify medical professionalism in strict accordance to corporate SOP’s/guidelines
- M.D./D.O., M.D.Ph.D., Ph.D. board certified/eligible
- Conduct Ad Boards, develop and maintain relationships with top thought leaders, and utilize medical insights from the field teams to inform the Medical Product Plan
- Deliver and execute local Medical Product Plan aligned with Global Medical Product Plan
- Identify and implement appropriate high-impact medical research projects to support the strategic objectives, including Alexion–sponsored and investigator initiated projects
- Collaborate with global medical education team to localize (and develop as needed) medical content for scientific exchange by field medical team
- Review and approve promotional materials to ensure information is accurate, relevant to the Country environment, and ensure medical accuracy
- Support medical information function, ensure timely response to medical information inquiries and collation of requests, utilizing global medical information resources and in line with local regulatory requirements and company policy
4
Experience For Senior / Medical Director, Medical Affairs Resume
- Ensure effective team communication, performance and documentation of medical affairs activities and knowledge through the application of suitable reporting systems and structures
- Identifying training needs in collaboration with key stakeholders and ensure implementation of medical training programs for the field medical team as well as other cross-functional members as appropriate
- Collaborate with Clinical Operations to manage the in country Clinical Operations Lead role and ensuring their activities are prioritized to meet the clinical operations and country objectives
- Developing and executing a highly efficient, integrated US medical affairs/scientific strategy, including scientific evidence generation and scientific information exchange with all key stakeholders
- Ensuring that all data generated by the company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
- Interacting with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in the therapeutic area Also, maintaining external orientation by participating actively in external asthma and allergy events and activities
- Identify physicians with excessive length of stay and cost/case, as well as those with readmissions within 30 days
- Work closely with Medical Staff Office with regard to physicians’ satisfaction
5
Experience For Medical Director & Medical Affairs Lead Resume
- Participate in Patient Safety Committee, PICC and other Quality/Safety conferences
- Develop/attend departmental morbidity/mortality conferences
- Partner and collaborate with the medical staff leadership
- Assist in development of physician leadership and collaboration
- Establish safety and improved outcomes as the key to enhancing stature, securing high level practitioners, developing best practices, establishing centers or excellence, attracting more volume and improving balance sheet
6
Experience For Senior Medical Director Medical Affairs Resume
- Mentor and exert influence over improving poor practice patterns amongst physicians, work on clinical documentation and within programs in collaboration with physician advisor
- Protect patients and the institution from rogue physicians and practice patterns
- Successful execution of key aspects of the Medical program for a novel product in development for migraine prevention
- Contribute to the development, execution and communication of the US Medical Team (USMT) product plan
- Serve as a key Medical point of contact in the launch process to ensure alignment between medical and brand activities; partner closely with the US Commercial team to ensure accuracy and appropriateness of promotional content development and ensure accuracy and appropriateness in promotional review
- Contribute to the design and execution of phase 4 clinical trials and observational research to support clinical and commercial activities in partnership with Development Operations, Center for Observational Research and Global Health Economics
- Contribute to and/or lead execution of medical Advisory Board Meetings
- Participate in review of US Non-Amgen Sponsored Clinical Research (NASCR) proposals
- Lead a matrix medical affairs team comprising of Medical Science Liaisons (MSLs), Medical Communications, HEOR, and Medical Information in the development of a scientific platform and a medical strategic plan
7
Experience For Lead / Medical Director, Medical Affairs Resume
- Provide medical input in the review and approval of promotional materials
- Develop and execute the Urology Medical Plan/Strategy for therapeutic area within the Medical Affairs department
- Partner with Commerical Operations and Clinical Development for strategic alignment and life-cycle management
- Provide scientific/medical consultation to the commercial team to ensure accuracy and compliance with FPI and FDA standards
- Maintain a high level of technical expertise in evaluation and interpretation of medical and scientific literature and extrapolate data for medical and commercial initiatives in the Urology field
- Establish relationships and share insights from engagement with Thought Leaders, healthcare providers, medical/professional societies, payers and patient advocacy groups
- Manage, generate and disseminate clinical and non-clinical data that supports the medical strategy and results in high quality publications
- Develop post-marketing clinical development plans including the design and management of clinical studies (Phase IV) and provide medical expertise in managemenet of IITs
- Continuously review the competitive position of projects and products including competitor actions to share insights and provide guidance from Medical Affairs
8
Experience For Senior Medical Director, Medical Affairs Resume
- Contribute medical/scientific expertise in medical or marketing educational initiatives, responding to off-label product-based questions and to the objective representation of data, product positioning, on-label promotion and the legal/medical/regulatory review process
- Outstanding presentation and interpersonal
- Active affiliations/reputation in medical/ scientific societies and academic teaching facilities
- Knowledge of clinical trial methodology and regulatory requirements
- Engage KOLs and form Advisory Committees from personal contacts
- Work well with others and establish consensus and compliance
- Lead the development and delivery of medical advisory boards
9
Experience For Medical Director, Medical Affairs Americas Resume
- Team responsibilities include U.S. medical affairs support for pre-launch products and indications, including strategic and tactical planning and design, implementation and timely completion of Phase IV studies and addressing post-marketing concerns
- Medical Director: MD with 5-7 years of industry experience in Neuroscience with at least 2 years of in-house Medical Affairs experience or Ph.D. with 10+ years of industry experience in Neurology with at least 5 years of in-house Medical Affairs experience
- Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area. Experience reviewing promotional materials from a medical perspective, publications planning, relevant medical society membership and track record of active participation/attendance, and strong presentation skills
- Provide key input to the Medical Affairs Strategy Team and medical affairs expertise and strategic input to various Medical Affairs and cross-functional teams
- Partner with commercial, clinical development, and other key functions to execute on product strategy based on external and internal input
- Foster relationships with key researchers and clinicians and solicit input from key medical opinion leaders, including through the planning and execution of medical advisory boards
- As a content expert, review abstracts, manuscripts for publications, scientific symposia presentations, and other medical documents as required
- Help provide leadership for all Medical Affairs activities
- Ensure that all Medical Affairs initiatives are compliant with corporate policies and regulatory requirements
10
Experience For Medical Director, Medical Affairs, Oncology Resume
- Identify, establish and maintain collaborative relationships with key investigators and institutions strategic to the appropriate use of company products
- Effectively communicate Array’s scientific position on products and targeted disease states to KOLs, academic and scientific organizations, payers, government, and regulatory bodies in the US, establishing and conveying product clinical relevance
- Collaborative style both internally with other company leadership, but also with external thought leaders, medical professionals, and partners
- A team player; works well in a team environment both as a leader and a contributor
- Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex clinical program independently
List of Typical Skills For a Medical Director, Medical Affairs Resume
1
Skills For Medical Director Medical Affairs Resume
- Excellent skills working with experts from other functions influencing decision making without authority in a complex and matrix environment
- In-depth understanding of and proven success in how to conceptualize, design, and conduct clinical trials
- Strategic thinking, strong project management, problem-solving ability, customer focus, and a recognized commitment to quality
- Demonstrated ability to create and lead successful cross-functional teams in changing, competitive environments
- Experience working in a pharmaceutical medical affairs function
- Strong working knowledge of current regulatory and compliance requirements
- Experience in the pharmaceutical industry,
- Helping to ensuring consistency of clinical content and scientific messages across publications and materials
- Providing US-focused medical input into global Development strategy, study design and deliverables (e.g., protocol, CSR, manuscript)
2
Skills For Associate Medical Director, Medical Affairs Resume
- Planning in support of business, clinical and scientific strategy
- Understanding and success in dealing with different cultures
- Providing leadership and strategic direction for interactions and communications with external customers, key organizations, and institutions
- Collaborating the health economic team to address questions and opportunities
- Complete understanding of current reporting requirements, pharmaceutical regulations and compliance issues concerning medical affairs functions
- Support U.S. Medical Director in leading monthly and quarterly reviews of US medical affairs activities, including field medical activities
- MD/DO, Specialty training in Internal Medicine or Pediatrics with additional subspecialty training in Allergy or Pulmonary Disease
- Inspire confidence, both internally and externally in Sanofi Oncology- leading by example and demonstrating collaborative behavior
3
Skills For Medical Director, Medical Affairs, Neurology Resume
- Work closely with all Chairs regarding OPPE and FPPE using electronic product
- Play an active role in sentinel events and root cause analysis to insure proper error vetting and reporting
- Assist the Credentials Committee in vetting credentialing issues
- Leverage all GuideWell assets in maximizing customer clinical value proposition
- Keep abreast of emerging models in health care delivery; identify and define new and innovative strategies to achieve business goals and objectives
4
Skills For Senior / Medical Director, Medical Affairs Resume
- Partner with sales teams in developing strategy for target client groups
- Review existing clinical data/results to 'create the story' that clearly communicates clinical value to the customer
- Recommend system enhancements to aid in client reporting
- Define the country Medical resource needs, and manage budget planning and resource allocation
- Work with all Chairs to get the performance evaluation done on every employed physician using My Success Performance Management System
- Discuss activities at Chair's meeting
5
Skills For Medical Director & Medical Affairs Lead Resume
- Close the loop on adverse patient events with physicians, nurses and chairs including action plan and follow up
- Establish a working relationship with the Chief Quality and Safety Officer in order to synergize Safety and Quality issues
- Lead internal medical educational initiatives (e.g, field medical training), and lead external educational, disease-state programs
- Work in, and enable a positive team environment and interact with local and global clinical, scientific and marketing teams
- (mostly within US)
- Strong understanding of all phases of product development, including pre-clinical development, clinical trial management, post-approval studies, regulatory and manufacturing compliance
- Data generation in the US (including Ph4, HE, Observational, and Non-Amgen Sponsored Clinical Research (NASCR)) in partnership with Development Operations, Center for Observational Research and Global Health Economics in support of global development and regional strategies
- Demonstrated focus on patients’ interest
- Developing US advocacy plan in partnership with Medical Communications, US Value & Access, and Global Development
6
Skills For Senior Medical Director Medical Affairs Resume
- Lead and execute Medical Advisory Boards in order to understand and address unmet medical needs
- Provide physician leadership and direction for the implementation of clinical strategy in key individual markets
- Clinical Lead to provide clinical direction for Health & Wellness Promotions and care partners/vendor management teams
- Develop/maintain relationships and interface with internal stakeholders (e.g., sales team, operations, products) to ensure that customer needs and strategies are being met
- Develop/maintain intimate relationships with applicable stakeholders within the customer experience
- Develop the business case for affordability and quality initiatives, and communicate and champion them with the customer
7
Skills For Lead / Medical Director, Medical Affairs Resume
- Identify and leverage cross-segment resources and relationships (e.g., with Clinical Management, Network) to help coordinate and drive consistent approaches that achieve relevant customer solutions
- Provide direction for dissemination of best practices/solutions across the enterprise (e.g., clinical, network, member incentive structures, provider strategies, fraud/abuse, contractual issues)
- Identify opportunities to collaborate and develop clinical integration opportunities within the Enterprise and the industry to achieve affordable, high quality outcome
- Actively engage in identifying business development opportunities
- Presents products, programs, philosophies and care value proposition to internal and external stakeholders
- Develop relationships with current and potential clients
8
Skills For Senior Medical Director, Medical Affairs Resume
- Conduct/participate in Broker/Client presentations and customer consultations
- Identify trends and patterns via analysis of data; recommend resolution and provide perspective in collaboration with Sales, Health Delivery, Marketing, and other internal customers
- Assist with and edit RFP content
- Assist with recommendations as to appropriate benefits and wellness programs for clients
- Serve as SME for Clinical Client relationships and solutions
- Monitor marketplace trends and gather competitive intelligence
9
Skills For Medical Director, Medical Affairs Americas Resume
- Maintain clinical core competency
- Participate in project and program development in consort with operational leadership and work professionally in a collaborative team environment
- Lead and provide direction for health promotion and wellness initiatives for group and individual customers
- Collaborate with and leverage retail center wellness and health promotion opportunities
- In partnership with Corporate Development evaluate potential health promotion and wellness business opportunities
- Work with care management to ensure appropriate support of client specific care programs
- Meet with targeted physicians to share performance data cost, use and quality, and support alternative care delivery models such as PCMH
- Lead physician advisory panels
- Act as key clinical lead for BCBSA /clinical affairs
10
Skills For Medical Director, Medical Affairs, Oncology Resume
- Act as key clinical lead for medical professionals association
- Act as key clinical lead for governmental affairs
- Gather Insightful information: understand customers’ needs and translate into the comprehensive Data Generation and Communication Plan. Execute the plan in collaboration with the Publication Team
- Act as a “Scientific Ambassador” to outside stakeholders, reinforcing the external perception of UCB as a leading Biopharmaceutical company
- “Peer” within UCB to build an effective and broad collaborative network throughout the company, going beyond the needs for immediate success, to contribute to others’ objectives and to projects that further our business and processes at UCB
List of Typical Responsibilities For a Medical Director, Medical Affairs Resume
1
Responsibilities For Medical Director Medical Affairs Resume
- Prior pharmaceutical industry experience is required, e.g. medical affairs or clinical development
- ICMJE guidance and Good Publication Practices
- Minimal clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent
- Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects/schedules, etc
- Two (2) years of clinical research experience and/or basic science research in Oncology
- Ethics and values with Integrity and Trust
- In medical affairs
2
Responsibilities For Associate Medical Director, Medical Affairs Resume
- Completion of residency program
- Accredited fellowship in Neurology, preferably in Headache
- MD with US licensure or fellowship required
- Expertise in genetic disease and metabolic diseases desired
- Medical speciality in pediatric neurology highly desirable
3
Responsibilities For Medical Director, Medical Affairs, Neurology Resume
- The highest personal integrity; committed to ethics and scientific standards
- High energy and absolute commitment to culture
- A “lifelong” learner who consistently seeks opportunities to learn
- MD, Board certification or other higher medical and academic qualification.Expertise (i.e. board certification)in Dermatology required
- Understands the impact of communication messages on others. Uses professional judgement and carefully crafts his/her communication by taking the listener’s perspective into consideration and by focusing on the goal of establishing a clear understanding/agreement
4
Responsibilities For Senior / Medical Director, Medical Affairs Resume
- Builds actively on long-term relationships, both internally as well as externally across different functions
- Remains focussed on end-goal, adjusts actively plans in terms of scope
- Adapts pro-actively project plan through involved of all relevant stakeholders, sets plan off against business time lines
- Lead cross-functional projects across matrix and geographies is essential
- Communicate with people of different cultures and present complex knowledge in an accessible manner
- Board Certified in specialty (highly desirable)
5
Responsibilities For Medical Director & Medical Affairs Lead Resume
- State Licensure to practice medicine (highly desirable)
- Maintain Board Certification eligibility
- Current ACCME guidelines
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc
- Championing medical strategy: the incumbent is pivotally involved in developing the overall Mission strategy by providing unique medical insights. He or she is a reference source for the Dermatology therapeutic area, patient solution team, and Regional colleagues, and ensures appropriate communication of global strategy horizontally and vertically in the medical organisation
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