by Dr Glenn Carter
1. Emails
2. Phone Calls
3. Internal Meetings
4. External Meetings
5. Travel
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:
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?)
Phone Calls
There will also be phone calls from:
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:
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
Internal Meetings
The focus during the Health Economics meetings is on
reimbursement and market access:
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:
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:
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.
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.