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A Day in the Life of a Medical Director by Dr Glenn Carter
21
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Page 1: A Day in the Life of a Medical Director

A Day in the Life of a Medical Director

by Dr Glenn Carter

Page 2: A Day in the Life of a Medical Director

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.

Page 3: A Day in the Life of a Medical Director

Medical Director’s activities

1. Emails

2. Phone Calls

3. Internal Meetings

4. External Meetings

5. Travel

Page 4: A Day in the Life of a Medical Director

Medical Director’s activities

1. Emails

Page 5: A Day in the Life of a Medical Director

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”

Page 6: A Day in the Life of a Medical Director

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

Page 7: A Day in the Life of a Medical Director

Medical Director’s activities

2. Phone Calls

Page 8: A Day in the Life of a Medical Director

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"

Page 9: A Day in the Life of a Medical Director

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.

Page 10: A Day in the Life of a Medical Director

Medical Director’s activities

3. Internal Meetings

Page 11: A Day in the Life of a Medical Director

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.

Page 12: A Day in the Life of a Medical Director

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.

Page 13: A Day in the Life of a Medical Director

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.

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Internal MeetingsIn 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.

Page 15: A Day in the Life of a Medical Director

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

Page 16: A Day in the Life of a Medical Director

Medical Director’s activities

4. External Meetings

Page 17: A Day in the Life of a Medical Director

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.

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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.

Page 19: A Day in the Life of a Medical Director

Medical Director’s activities

5. Travel

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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.

Page 21: A Day in the Life of a Medical Director

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.