The Medical Director oversees all activities of a company's Medical Department and contributes to senior leadership. Their day involves emails and phone calls about clinical trials, regulations, and health economics. They attend internal meetings on research, regulations, reimbursement, and business strategies. External meetings include advising investigators and regulators. As the senior medical advisor, they provide clinical guidance across the company.

1. A Day in the Life of a Medical Director
Dr Glenn Carter
Healthcare Professionals Group

2. 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.

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

4. Emails
Head Office questions requesting updates on clinical trials, 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”

5. Phone Calls
Calls will be received from trial investigators about Inclusion/ Exclusion criteria, or the clinical
protocol:
"My patient is also taking x drug can I enrol him";
"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"

6. 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, and would have undergone media training.

7. Internal Meetings
In the Clinical Research meetings a whole range of issues will be discussed. Progress made in all
the clinical trials will be regularly reviewed. 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. This will involve reviewing protocols sent from Head
Office, discussing whether they are applicable to Australian medical practice and identifying
potential investigators.

8. Internal Meetings
In the Regulatory meetings the topics will include:
 registration of New Chemical Entities, new dosage forms and new indications
 updates on timelines for regulatory submissions
 discussion on bottlenecks and issues which may delay registration.
 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, with approval being given by the Medical Director prior to
printing and distribution.

9. 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, as well as suitable
gold standard comparator treatments relevant to medical practice in Australia.

10. Internal Meetings
The Medical Director is also involved with across-company meetings.
The Medical Director's medical knowledge and understanding of how patients are treated is useful
when annual marketing plans are devised. Topics during these meetings include:
 sales forecasts
 market trends
 competitor activity
 promotional programs
 disease management programs
 patient characteristics
 prescriber behaviour

11. Internal Meetings
During senior management meetings (also attended by the Managing Director, Sales and Marketing
Director, Operations Director, Human Resources Director and Finance Director) the Medical Director
will contribute to across- business 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

12. 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.

13. 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.
External meetings will also include co-visiting doctors with CRAs to discuss current and future
clinical trials, and with sales reps to discuss the company's marketed products.

14. 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.
Regional offices (eg Singapore) or global Head Office (US, UK or Europe) for meetings with internal
colleagues to build relationships; to request resources and headcount for Australia and to provide
updates on clinical trials and regulatory, reimbursement and other medical issues

15. Summary
The typical day of a Medical Director within an Australian pharmaceutical company is varied and
complex.
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,
regulatory, medical information, reimbursement and sales and marketing issues.
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.

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