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A Day in the Life of a Medical Director

by Dr Glenn Carter

Medical Director’s role
The role of a Medical Director is to oversee all activities
within a company's Medical Department and to contribute
to company-wide business operations through
involvement in the senior leadership team.

External Meetings 5.Medical Director’s activities 1. Internal Meetings 4. Phone Calls 3. Travel . Emails 2.

Medical Director’s activities 1. Emails .

regulatory or health economics submissions eg “How is patient recruitment going in x trial”? “What did x investigator think about the draft protocol for the new trial”? “How many patients will Australia be able to commit to the global clinical trial program for x compound? “Here are the results from x trial to discuss with your investigators” “Here are the responses to the questions the TGA are asking about the compound which is being reviewed for registration” “Here is some additional data to include in the reimbursement submission” “Here is a report on the serious adverse events in x trial” .Emails Head Office questions requesting updates on clinical trials.

key opinion leaders. patient associations Internal emails focusing on the business operations: • • • • agendas for meetings finance issues training and people management sales and marketing initiatives . advisory boards. questions from investigators) requests for funding to support additional patient recruitment updates from discussions with regulators.Emails Emails from the Medical Director to Head Office would include: • • • clinical trial updates (patient recruitment.

Phone Calls .Medical Director’s activities 2.

"If the patient had missed 2 visits can they continue in the trial?) Calls will also be coming in from CRAs who are on-site at hospitals doing monitoring visits "The study nurse needs more drug and I need your help in getting head office to send it quickly" . or the clinical protocol: "My patient is also taking x drug can I enrol him".Phone Calls Calls will be received from trial investigators about Inclusion/ Exclusion criteria.

and would have undergone media training.Phone Calls There will also be phone calls from: • • • • the press asking for a response to an overseas news piece patient associations regarding sponsorship doctors requesting patient-specific medical advice investigators asking to have their own trials supported As the medical leader within companies the Medical Director is frequently asked to publicly comment on a range of topics. .

Internal Meetings .Medical Director’s activities 3.

discussing whether they are applicable to Australian medical practice and identifying potential investigators. . Topics of conversation will centre around: • • • • • • Ethics Committee approvals strategies to increase patient recruitment availability of trial materials site issues and management trial budgets and payments adverse event reporting New trial protocols will also be discussed. Progress made in all the clinical trials will be regularly reviewed. This will involve reviewing protocols sent from Head Office.Internal Meetings In the Clinical Research meetings a whole range of issues will be discussed.

Internal Meetings In the Regulatory meetings the topics will include: • • • • • registration of New Chemical Entities. correspondence from the TGA will be reviewed and appropriate responses drafted the wording of PIs and CMIs will be finalised During the Medical Information meetings company promotional literature will be analysed to ensure that it meets Code of Conduct guidelines. . new dosage forms and new indications updates on timelines for regulatory submissions discussion on bottlenecks and issues which may delay registration. with approval being given by the Medical Director prior to printing and distribution.

as well as suitable gold standard comparator treatments relevant to medical practice in Australia. .Internal Meetings The focus during the Health Economics meetings is on reimbursement and market access: • • • • • the strategy for PBAC submissions will be decided upon the clinical data supporting the pricing strategy will be analysed additional supporting trials or analyses will be considered input from consultants (eg on economic modelling) and direction from head office (eg on international pricing) will be used to determine the negotiation strategy with the PBAC discussion on the design of future clinical trials to ensure that they collect the right information for submissions The Medical Director's input will also include suggesting disease relevant health status questionnaires and Quality of Life instruments to incorporate into the trial design.

. Topics during these meetings include: • • • • • • • sales forecasts market trends competitor activity promotional programs disease management programs patient characteristics prescriber behaviour The Medical Director will also speak at the company's national sales conference and product launches where they will discuss clinical trial results and facilitate disease area training. One of these will involve having strategic input into the marketing meetings. The Medical Director's medical knowledge and understanding of how patients are treated is useful when annual marketing plans are devised.Internal Meetings In addition to Departmental meetings the Medical Director is also involved with across-company meetings.

Sales and Marketing Director. Operations discussions where a wide range of topics will include: • • • • • • • • • operational and strategic planning resource management learning and development plans succession planning manufacturing and supply chain issues policy development external and corporate affairs initiatives crisis management monitoring of the company's trading and cash flow position . Human Resources Director and Finance Director) the Medical Director will contribute to across.Internal Meetings During senior management meetings (also attended by the Managing Director.

External Meetings .Medical Director’s activities 4.

External Meetings The Medical Director may be responsible for assembling and managing Key Opinion Leader advisory groups for key products. . The advisory group's role is to: • • • • review particular products (pre-launch or marketed) discuss where the product fits into the management of the patient's disease to suggest synergies with other company products to discuss leading developments in the field Information gained during these discussions is then summarized and made available to marketing and R&D functions.

and with sales reps to discuss the company's marketed products. . External meetings will also include co-visiting doctors with CRAs to discuss current and future clinical trials.External Meetings It is also likely that the Medical Director will participate in Medicines Australia and other industry committees thus ensuring that their company has a high level of professional standing.

Travel .Medical Director’s activities 5.

Regional offices (eg Singapore) or global Head Office (US. . UK or Europe) for meetings with internal colleagues to build relationships. reimbursement and other medical issues. to request resources and headcount for Australia and to provide updates on clinical trials and regulatory.Travel Canberra to meet with the TGA to discuss scientific and clinical data with the regulators and build on-going relationships with key people. Overseas meetings with Medical Directors from other countries there will be discussions on global clinical development programs. regulatory timelines for key compounds and strategies to gather data in support of reimbursement and market access.

. As a member of the senior leadership team they use their medical knowledge and commercial acumen to contribute to the overall success of the company. As the company's senior medical person they are called upon to use their clinical knowledge and understanding of patient treatment protocols to advise their internal colleagues on clinical research.Summary The typical day of a Medical Director within an Australian pharmaceutical company is varied and complex. regulatory. reimbursement and sales and marketing issues. medical information.