Senior Medical Director Resume Sample
Carlie Dickinson
7193 Caterina Unions,
Chicago,
IL
+1 (555) 751 8095
Work Experience
Senior Medical Director
11/2017
-
PRESENT
San Francisco, CA
- Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
- Demonstrated independence, initiative and the ability to work well in a fast-paced environment
- Travel time is approximately 15% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings
- Willingness to travel to both internal and external meetings, including overnight trips. National and international travel is required
- Reviews cases, makes medical necessity determinations, and conducts peer to peer reviews
- Ensures compliance with case management and disease management programs and clinical goals through regular monitoring of case management center performance
- Participates in case rounds and development of case management plans for individual members
- Evaluates the effectiveness and cost of care of clinical programs through review and analysis of utilization and financial data., Assists with root cause analyses and enterprise resolution of issues; modifies programs as needed to achieve desired results
Senior Medical Director, Clinical Development
11/2014
-
09/2017
Los Angeles, CA
- Chairs the Regional Network Credentialing Committee (RNCC) and the Quality Improvement Committee (QIC). Develops and provides leadership for NCQA compliant clinical quality improvement activity (QIA) in collaboration with key stakeholders. Participates in QI projects
- Recruits, trains, supervises, mentors, oversees and evaluates the quality of medical staff and physician advisors. Ensures adequate physician resources. Develops and manages medical director and physician advisor budgets, travel budgets, and continuing medical education budgets
- Develops and implements the Medical Action Plan (MAP) to address the cost of care for all health plans overseen by the assigned position which includes metrics for utilization and quality management. Develops mitigating strategies to ensure goals are met or exceeded. Works closely with the clinical care management to ensure effective staff case review
- Assesses technology and clinical practice standards developed by the company, and participates in management of the inter-rater reliability process to ensure consistency between reviewers
- Monitors quality and quantity of clinical reviews and care plans
- Provides after hours coverage as required
- Act as the Medical Affairs representative on key cross-functional product and development strategic focused teams
- Lead the Medical Affairs cross-functional Product Team
- Represent Medical Affairs on relevant commercial teams: Launch Team, and Global Brand Teams for marketed products
Senior Medical Director Mltss
03/2010
-
09/2014
Phoenix, AZ
- Market relationship and access development
- Manage contact with global KOLs, particularly for Pipeline products, ensure appropriate access to KOLs during entire product lifecycle
- Provide oversight for international symposiums, advisory boards, manuscripts
- Develop Medical Affairs global product launch strategy and roadmap and lead all Medical Affairs global launch activities in collaboration with Commercial and other key stakeholders
- Filing / Regulatory
- Assist in writing medical need, natural history and risk/benefit sections of BLA and MAA
- Represent Medical Affairs at FDA/EMA advisory board meetings
- Post Marketing – Registries, IR, observational
Education
Argosy University - Seattle Campus
2004 - 2009
Science's Degree in Business
Professional Skills
- Present opinions and recommendations persuasively and authoritatively utilizing compelling information, strong influencing skills, personal credibility and strength of one’s convictions and commitment
- Demonstrate excellent presentation skills, clearly conveying scientific content in a structured, organized manner
- Excellent communication and collaborative skills with experience working with global cross-functional groups
- Excellent management, teamwork, communication and presentation skills and solid experience in developing strategic plans and oversight processes
- Demonstrated leadership skills in managing, developing, and influencing teams
- Demonstrate good problem-solving and interpersonal skills
- Excellent communications skills (verbal and written); capable of articulating the Company's clinical strategies and results to worldwide audiences
How to write Senior Medical Director Resume
Senior Medical Director role is responsible for leadership, interpersonal, presentation, clinical, medical, cross-functional, powerpoint, excel, direct, research.
To write great resume for senior medical director job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Medical Director Resume
The section contact information is important in your senior medical director 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 Senior Medical Director Resume
The section work experience is an essential part of your senior medical director 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 senior medical director responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior medical director position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Medical Director resume experience can include:
- Strong influencing skills: proven abilities to get things done without formal authority
- Proven track record of meeting or exceeding objectives and goals and effectively developing and managing Phase IIIb/IV clinical studies
- Prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
- Effectively interact with and collaborates at all levels in the organization, including effective interface at the senior management level
- Strong organizational, problem solving, and project management skills
- Ten years management experience and prior executive oversight experience in a clinical setting
Education on a Senior Medical Director Resume
Make sure to make education a priority on your senior medical director resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior medical director 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 Senior Medical Director Resume
When listing skills on your senior medical director 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 senior medical director skills:
- Clear and effective oral and written communication skills and the ability to effectively present information to pubic groups and upper level management
- Supervisory skills including clinical mentoring and coaching skills
- Demonstrate excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside Regeneron
- Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Kite
- Outstanding writing, as well as good communication and interpersonal skills
- Excellent speaking skills to include giving presentations at industry conferences and meetings
List of Typical Experience For a Senior Medical Director Resume
1
Experience For Senior Medical Director, Clinical Development Resume
- Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage internal and external partnerships
- An excellent scientific track record demonstrated by publication record in refereed journals
- Experience in clinical science and drug development is desirable
- Experience with developing and maintaining external clinical partnerships
- Experience leading or participating in complex, industry drug development collaborations
2
Experience For Senior Medical Director, Lemtrada Team Lead Resume
- Responsible for effective interviewing, selection, orientation, development, and retention of urgent care providers
- Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOLâs
- Drug development experience in the biotechnology or pharmaceutical industry required
- Demonstrated leadership of multiple development projects and teams
- Ensures cost effective delivery of health care within the urgent care practice management operations
3
Experience For Senior Medical Director Mltss Resume
- Ensures medical activities run according to GCP and operate with highest efficiency
- Willing to take initiative on advancing projects and able to identify what is necessary to complete tasks
- Monitoring epidemiology studies to ensure appropriate methods are being used, including formulating hypothesis, study design, analysis, and report writing
- Providing interpretation of data from patient registries as well as giving input on registry design
- Provides leadership to direct reports by cultivating a supportive, motivating and collaborative work environment
- Lead for development/design of global PMC/PMRs and studies falling under Medical Affairs scope in coordination with Medical Affairs Study management
- Act as medical monitor for global PMR/PMC and studies falling under the Medical Affairs scope in collaboration with Medical Affairs Study management
- Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising during clinical investigations and preparing reports to the management and medical community
4
Experience For VP, Senior Medical Director Resume
- Collaborates with bidders in establishing parameters for business deliverables
- Exudes a leadership style emphasizing collaboration, teamwork, participation and communication
- In collaboration with Regional Medical Product leadership and Area Medical Leads, conduct critical scientific and medical review of IR protocols
- Support early disease training across the company. In collaboration with Medical Affairs learning and development department develop content and modules for training
- MD with county licensure or fellowship required
- Provides extensive medical expertise and strategic planning for clinical activities supporting the development, launch, adoption, and reimbursement for products and services including
- Management responsibilities include onboarding, salary administration, performance management including promotion and discharge activities, conflict resolution, recruiting and mentoring for direct reports
- Assists direct reports as needed with sponsor communication and provides direction and feedback on implementing scope of work
- Assists and oversees direct reports with study startup activities
5
Experience For Senior Medical Director for Oncology Resume
- Identifies unusual or significant project related concerns encountered for self or a direct report and proposes strategies for preventing or correcting significant problems
- Maintains understanding of contracts and budgets, project billing, expense submission and travel
- Attends MD management calls as well as regional physician calls
- Presents PPD standard medical/safety processes to prospective clients at business development meetings, and communication with medical communities to explore and expand PPD business. This includes participation in business development opportunities (e.g. networking) at educational conferences and meetings
- Participates in strategy calls, proposal development and bid reviews
- Provides regional leadership and participates on cross-functional enterprise initiatives
- Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle
6
Experience For Medical Director / Senior Medical Director Resume
- Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs
- Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately
- Provides therapeutic training and protocol training on assigned studies, as requested
- Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete
- Provide medical/scientific input and drive the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc
- Review and sign off all clinical documents related to First-in-Man (FIM) and PoC studies (e.g. study protocols and study reports), supervise the review, analysis and interpretation of study data. Support communication of study results as assigned
- Responsible for the medical supervision of assigned projects/programs
7
Experience For Senior Medical Director, Psychiatry Resume
- Biostatistics, Business Development, Business Unit/Marketing, TA Oncology, Chief Medical Officer, Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance
- Health Authorities, Opinion/Thought Leaders, Clinical Investigators, Academic Institutions, Scientific and Patients’ Organizations
- Lead the development of the Medical Affairs Plan for assigned products and accountable for execution
- Partners with HEOR lead to drive HEOR gap analysis, and ensure projects to address these gaps are reflected in the Medical Affairs Plan and support the creation of the Core Value Dossiers and other outputs needed to support access
- Contribute in discussions with R&D colleagues and ensure that Medical Affairs’ perspectives are provided and incorporated in development plans
- Build and maintains relationships with experts and able to obtain important key scientific insights to support the therapeutic area
- Effectively lead matrix teams of functional colleagues; ensure effective cross-functional collaboration; align all key Medical Affairs projects for assigned product and indication. Champion an objective and evidence-based solution oriented approach
- Related experience, including 12+ years of management experience
8
Experience For Senior Medical Director of Oncology Resume
- Strong strategic thinking acumen and track record for operational excellence
- Demonstrated strength in business planning, tactical plan development and execution
- MD/DO/PharmD/PhD or equivalent with expert knowledge in neurology or psychiatry therapeutic areas
- Experience in successfully leading cross-functional matrix teams either within Medical Affairs or clinical development. The ability to influence without direct authority is a critical skill set for this role
- Has full understanding of rules and regulations in pharma, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines and regulations and is able to apply legal and compliance knowledge to Medical Affairs activities
9
Experience For Senior Medical Director Oncology Resume
- Safety Surveillance and Rick Identification and Assessment Risk Management - Apply current regulatory guidance for risk minimization to AbbVie’s product safety, RMP/REMS plans, as appropriate
- Understand assigned products’ pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical AE profile
- Track known safety issues and potential safety concerns throughout the products’ lifecycle (Product Safety Plan)
- Ensure the development and execution of global, strategic medical plan in support of best clinical practices and overall corporate objectives aligned with Global Medical Affairs plans and commercial franchise strategy
- Lead the implementation of medical affairs practices to assess new indications, the treating community, patient pathways, identifying patients for clinical research and to develop a thorough understanding of the disease area
- Oversee quality, coordination and timeless of clinical sections of IND’s, Investigator Brochures, CTA’s, ISS’, ISE’s and clinical expert reports
- Responsible and accountable for input regarding the design, analysis, and interpretation of pharmacoepidemiology studies
10
Experience For Senior Medical Director Global Pv-gi Resume
- Responsible for participating in cross functional teams who assemble and interpret adverse event data from multiple sources
- Provides project leadership for the development and implementation of epidemiology methods and technology used in the assessment of risk
- Interacts with SERM Leads, and multifunctional team members who are responsible for safety evaluations to advise on pharmacoepidemiology best practices and risk assessment activities across Seattle Genetics programs.
- Directs the writing, and maintaining of policies and procedures that establish the standards for using epidemiology to understand/evaluate drugs safety
- Represent Drug Safety in Clinical Sub Team for assigned investigational products providing expert medical guidance regarding safety matters and issues
- Lead Safety Management Team for assigned pre-marketing and/or post-marketing product(s) and all associated risk management activities
- Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports
- Best represent Roche’s scientific excellence and high ethical standards when interacting with potential outside partners
List of Typical Skills For a Senior Medical Director Resume
1
Skills For Senior Medical Director, Clinical Development Resume
- Professional demeanor & excellent interpersonal skills when dealing with external customers /internal colleagues
- Proven strategic thinking skills and ability to interpret and implement strategic directions
- Excellent interpersonal skills and computer literacy, with proficiency in Microsoft Office products, including Word, Excel and PowerPoint
- Demonstrates wide range of acquired skills as head-office medical affairs product lead, with global and US remit
- Proven leadership skills in a cross-functional global team
- Demonstrates ability to present complex (medical) information to others effectively
- Proven leadership skills and ability to successful guide and influence a cross-functional team
- Exceptional time management and organization skills and the ability to manage multiple priorities
- Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
2
Skills For Senior Medical Director, Lemtrada Team Lead Resume
- Demonstrated ability and experience working cross-functionally, as well as influencing and negotiating at all levels within the organization
- Demonstrates an analytical approach to problem solving and ‘evidence-based decision making’
- Excellent relationship building capabilities and excellent ability to influence decision making without authority in a large matrix organization
- Demonstrate an analytical approach to problem solving and ‘evidence-based decision making’
- Interact effectively in a multifunctional multinational team setting
- Serve to develop, improve, and evaluate the critical thinking skills of the nurses, to achieve the highest quality and efficiency outcomes
3
Skills For Senior Medical Director Mltss Resume
- Embrace flexibility with great ability to apply transferable skills across programs and disease areas if required
- Demonstrated success implementing utilization and quality improvement strategies /techniques and experience with physician behavior modification is required
- Experience in direct patient care and a strong working knowledge of managed healthcare is required
- Experience in internal medicine, pulmonology and/or experience in orphan diseases
- Resolution and solution-oriented with the ability to work effectively in a client-focused, team environment
- Training and/or clinical practice experience in Alzheimer’s disease / dementia or other degenerative CNS disorders
4
Skills For VP, Senior Medical Director Resume
- Experience in developing and leading teams in changing competitive environment, changing product technology, and changing needs
- Operate as the principal manager in recruiting, selecting and directing the work of the medical review staff
- Demonstrated proficiency in communicating upward, downward and laterally, verbally and in writing
- Demonstrated ability to work with software tracking/logging systems
- Work and manage people in a matrix environment as well as experience in managing a team of >3 direct reports
- Organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
- Experience mentoring departmental staff
- Experience collaborating with various departments and investigators
5
Skills For Senior Medical Director for Oncology Resume
- Interact with NCI/CTEP regarding investigational studies with Takeda solid tumor molecules on CRADA
- Ensure effective cross-functional alignment in customer facing activities and represent Pfizer externally
- Presents as a knowledgeable and credible resource with solid knowledge of population health management, worksite health promotion programming and ROI
- Work experience in manufacturing or services industry
- Board certification in medical oncology and/or hematology, or foreign equivalent, or extensive oncology clinical development experience in industry (>7 yrs)
- Extensive experiences in interaction with Health Authorities in Europe, US and possibly Japan and/or China
- US strategy development for solid tumor malignancies including pipeline molecules and acquisitions
6
Skills For Medical Director / Senior Medical Director Resume
- Engages early (at lead optimization stage) with Neuroscience DDU to assist in research portfolio prioritization, based in part on translation strategy
- Participate in US Leadership Team to define and implement strategy for both solid tumor and hematologic malignancy applications
- Responsible for medical affairs clinical trials in solid tumor malignancies
- Extensive knowledge of Urgent Care operations; Strong knowledge of management practices, human relations, consensus building and collaborative ability
- In pharmaceutical industry with experience in leading registration-stage trials and significant interaction with global regulatory authorities
- Have relevant experience in industry or academia driving clinical development programs
- Experience leading cross-functional teams
- Experience managing people
7
Skills For Senior Medical Director, Psychiatry Resume
- Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required)
- Clinical trial or medical affairs experience in the pharmaceutical industry or equivalent
- Experience in the Pharmaceutical or biotechnology industry
- “Can do” attitude with a strong sense of initiative and ability to identify alternative options, devise and propose recommendations or solutions
- Experience in a business environment
- Bio/pharmaceutical industry experience in drug development
- Demonstrated competence as a results-driven leader and manager of people
- Experience applying scientific knowledge and insight to clinical development strategy and clinical study protocol
- Significant experience with clinical research is required
8
Skills For Senior Medical Director of Oncology Resume
- Experience in a Medical Monitor or clinical development oversight role within a clinical research organization or pharmaceutical company
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent
- Work to improve quality and promote evidence-based medicine
- Phase I-III Clinical trial experience in the pharmaceutical industry, academia, or equivalent
- Exercise good scientific and clinical judgment to proactively identify and address complex problems
9
Skills For Senior Medical Director Oncology Resume
- Translates current research into evidence based health promotion practices and population health management
- Demonstrates medical and scientific expertise to core business strategy and marketing/business development plans
- Understanding of Value Based Contracting/Accountable Care and how this relates to improving the quality of care for our members through collaboration
- Communicating and marketing the Optum practice model to new members and providers as well as other stakeholders such as the medical community
- Developing a working rapport with the medical provider network, emergency room providers, support services and others
- Successful history preparing and filing INDs and NDAs/BLAs resulting in drug approvals both in the US and preferably ex-US is desirable
- Provides global strategic decision making as a participating member of the Global Medical Therapeutic areas leadership team
10
Skills For Senior Medical Director Global Pv-gi Resume
- Verify the accuracy of training material for scientific and product information and drug safety reporting requirements to the local organization
- Intellectually curious with a passion for developing innovative pharmaceutical drugs. Creative, "thinks outside the box," willing to take responsible risks
- Medical reviewer for product/therapeutic area Marketing and Advertising Review Committee materials
- Key point of contact with Steering Committees, Advisory Committees, Data Monitoring Committees, and Publication Committees
- Obtain pharmacogenomics information for possible reflection in FDA labeling and prescribing guidance for clinicians
- Provide medical information on existing and emerging data in response to questions from internal and external stakeholders
- Collaborates with the Marketing Lead in the ongoing development of population health management capabilities
- Comprehensive health plans including medical, dental and vision
List of Typical Responsibilities For a Senior Medical Director Resume
1
Responsibilities For Senior Medical Director, Clinical Development Resume
- Ensures effective quality assurance and risk management processes
- Hands-on experience in the creation and implementation of pharmaceutical Life Cycle Management programs
- Strong knowledge of the pharmaceutical/healthcare market, acceptable practices and related regulations is required
- Demonstrated ability to manage out-sourced projects including vendor/agency management
- Drug development or related experience
- Demonstrate Core Competencies as defined for Regeneron managers on a consistent basis
- Partnering with GCO to develop new and enhance existing client relationships where possible
- Helping set agendas / strategies and leading multifaceted teams of Physician Business Managers, Risk Adjustment RNs, and Quality RNs
- Collaborate with physicians to develop clinical programming by accessing and mining clinical data, devising methods to manage populations
2
Responsibilities For Senior Medical Director, Lemtrada Team Lead Resume
- Assess the overall team, including ongoing recruitment and hiring of talent
- Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) when such a Committee is constituted for a study
- Motivate and mentor UPMC Health Plan's clinical Medical Affairs staff by 'setting the pace' and fostering 'excellence by example'
- Assist with the monitoring and trending of utilization data, case management data and disease management data
- Supports decision-making responsibilities regarding medical matters
3
Responsibilities For Senior Medical Director Mltss Resume
- Attract and develop talent, coach and mentor others to higher levels of performance. Create an atmosphere of innovation and continual learning
- Ensures ongoing professional medical management development programs
- Oversight of development, training, maintenance and financial performance of HMS Contracted Physician Network
- Participate with CMO as directed in thought leadership activities (i.e. blog posts, conference speaking, white papers, etc.)
- Provides expert level consultation on epidemiological issues to a variety of stakeholders across Seattle Genetics programs
- Facilitate production and maintenance of risk management plans and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties
- Participate in continuous improvement activities including systems design, performance measurement and quality management
- Participate in alliance safety teams with external partner (s)
- Provide guidance and mentorship on pharmacovigilance, risk management best practices and safety science to safety operations personnel
4
Responsibilities For VP, Senior Medical Director Resume
- Expert for early first in human/Phase 1 clinical development matters on several cross-functional teams, incl. DST, Clinical Collaborations, ISTs and others
- Serve as DST leader; manage and coordinate cross-functional team meetings, facilitate discussions and develop DST-positions/recommendations for CMO-endorsement
- Oversee quality, coordination and timeless of clinical sections of INDâs, Investigator Brochures, CTAâs, ISSâ, ISEâs and clinical expert reports
- Develops and maintains the market’s clinical program’s strategic direction, assesses new opportunities, and leads a cross functional team to implement and/or improve programs
- Ensure a positive working relationship with all providers; create a culture of open progressive communication and mutual understanding between the physicians, PSA leadership and employees
- Establish a sense of mutual “pride of ownership” among constituencies, including physicians, employees and the PSA / MCHS community. Nurture a culture of shared purpose and goals among these groups, fostering greatly improved working relationships and ensuring consistent quality of patient care
- Through a close partnership with the PSA / MCHS Administrative Team, Clinical Operations, Patient Experience Group and Finance, to ensure goals and objectives are in alignment with market/corporate initiatives to meet the needs of a transformational health care environment
5
Responsibilities For Senior Medical Director for Oncology Resume
- Contributes to the development of Company policies involving medical, safety and therapeutics
- Participates in process improvement activities across Company
- Accountable for MA strategies and tactics of one or more compounds in late stage development or early launch
- Chair matrix team (e.g. Core Medical Team) of up to 10-15 colleagues for 2-4 indications/compounds with a monthly frequency
- Co-chair the Global Product Strategy Team for 2-4 indications/compounds
- Works independently. Can address complex problems within discipline or across several projects. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions
6
Responsibilities For Medical Director / Senior Medical Director Resume
- M.D. with board certification or eligibility in Oncology or Hematology/Oncology required
- Strategic agility; in-depth knowledge and broad experience in the pharmaceutical or biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives
- Strong interpersonal, influencing, presentation, and written and verbal communication skills; able to effectively address all levels within an organization and with external collaborators
- Act as the company’s senior scientific consultant and as the therapeutic area expert to internal Mallinckrodt stakeholders such as the Commercial organization/Brand Teams, Science and Technology, other GMA teams, etc
- Respond to questions and requests for information from regulatory authorities, ethics committees, and other review/oversight panels pertaining to Mallinckrodt’s portfolio
- Drug development experience in the biotechnology or pharmaceutical industry required
- Provides leadership and communication for all urgent care physician leaders, physicians and clinical staff
- Partners with medical management staff, to result in clinical process improvement activity and access enhancement
- Ensures customer satisfaction and compliance with regulatory standards
7
Responsibilities For Senior Medical Director, Psychiatry Resume
- Ensures that all NCQA and other accreditation standards are met
- Establish direct relationship with key departments including pharmacy, underwriting, medical adjudication, claims, and provider relations, and assist with issues and/or concerns
- Partner with LAB team to identify business opportunities on existing brands
- Interacts with clients regarding drug development programs, study design and protocol
- Work collaboratively with cross-functional teams, both internal and client, to define strategic medical objectives for brands
- Represents MSA in business development initiatives
- Act as a liaison between the agency and key consultants/opinion leaders
- Collaborate with Account Services to manage client relationships
- Exemplify medical professionalism and ensure strict compliance in strict accordance to corporate SOP’s/guidelines
8
Responsibilities For Senior Medical Director of Oncology Resume
- O North America Medical ‘point of contact’ for the designated medicine(s) within the Oncology therapeutic area. Responsible for medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines
- Establishes and maintains a network of medical/scientific consultants, etc
- Supervises and manages Medical Director activities
- Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables
- Provides project team training on protocol and/or therapeutic areas
- Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection
9
Responsibilities For Senior Medical Director Oncology Resume
- Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
- Presents protocol and/or safety reporting information at investigator meetings
- Develops project medical monitoring plans as requested
- Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues
- Develop the Reproductive Health and Women’s Health therapeutic areas and provide regular interaction with senior product and clinical management for strategic clinical development issues and clinical trial operations relating to R&D projects
- Responsible for the preparation of the US-initiated clinical development plans, medical input to Investigator’s Brochures, protocols, study reports, and the clinical part of the dossier
10
Responsibilities For Senior Medical Director Global Pv-gi Resume
- Demonstrated experience in scientific publication planning and implementation
- Ensure compliance with Good Clinical Practice
- Specialist in obstetrics and gynaecology with >5 years of clinical experience
- Demonstrated ability to work independently while adhering to Medical Affairs’ strategic direction
- Develop and support short- and long-term goals of Worldwide Medical with respect to prioritization of TECFIDERA research interests and collaborations
- Active affiliations/reputation in medical/scientific societies and academic teaching facilities
- Provide input and contribute to execution of the Globally-initiated development projects
- Liaison with Regulatory to ensure adequate input into dealing with clinical dossiers, and labelling matters as well as with Marketing for communication of product/trial data
- Contribute to assess medical safety in clinical trials, DSMB Management and risk management plan for projects in the therapeutic area in collaboration with Global and US Pharmacovigilance
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