Medical Director, Global Therapeutic Area, Transplant
Our client is a biotechnology company. They have asked us to assist them in a search for a Medical Director, Global Therapeutic Area, Transplant.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides strategic leadership and guidance for clinical development activities for a small group of Medical Directors.
- Collaborates with other MD managers and head of clinical to ensure adequate resourcing across the portfolio.
- Manages a team of development physicians, acts as a mentor to physician group to guide clinical development expertise in general and in specific areas of therapeutic knowledge.
- Defines global clinical development strategies for all projects in the therapeutic area.
- Ensures high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with regulatory agencies.
- Prepares for stage-gate evaluations and benefit–risk evaluations and assessments.
- Oversees and supports the clinical development activity of assigned Clinical Development reports and works with clinical development team leads and global project leaders to ensure optimal clinical strategy, CDP and protocol design to support optimal project strategies.
- Ensures that the patient and physician voice is at the forefront in strategy development.
- Builds networks with external experts.
- Drives excellence in clinical development execution.
- Partners with therapeutic area core, extended core & functional partners to provide scientific & medical clinical development & medical affairs activities.
- Enhances the reputation of the organization through thought leadership, KOL interactions in fundamental issues affecting the therapeutic area.
- Holds responsibility for effective presentations at STRC, TPRC, etc.
- An MD is required. Board Certification (or non-USA equivalent) in Internal medicine with relevant sub-specialty is highly preferred. If not Board Certified in a relevant subspecialty, then experience in that therapeutic area is a must.
- Must have clinical development experience in leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes.
- A minimum of 5 years’ experience preferred, acquired in either industry or academic positions. If academic experience is held, experience in working with industry sponsors is required.
- Must have outstanding influencing ability & collaboration skills.
- Requires proven leadership experience.
- The ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups is required.
- Must have experience interacting with Health Authorities and designing programs that meet the needs of HA’s, commercial and payers.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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