A Day in the Life of a Medical Director

by Dr Glenn Carter

Medical Directors 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.

Medical Directors activities

1. Emails
2. Phone Calls
3. Internal Meetings
4. External Meetings
5. Travel

Medical Directors activities

1. Emails

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

Emails
Emails from the Medical Director to Head Office would include:

clinical trial updates (patient recruitment, questions from investigators)

requests for funding to support additional patient recruitment
updates from discussions with regulators, key opinion leaders, advisory boards,
patient associations

Internal emails focusing on the business operations:

agendas for meetings

finance issues
training and people management
sales and marketing initiatives

Medical Directors activities

2. Phone Calls

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"

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.

Medical Directors activities

3. Internal Meetings

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.

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.

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.

Internal Meetings
In addition to Departmental meetings the Medical Director is also involved with
across-company meetings.
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. 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.

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

Medical Directors activities

4. External Meetings

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.

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.

Medical Directors activities

5. Travel

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.

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.