Senior Medical Director, Adaptive Immunity
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Medical Director, Adaptive Immunity.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Designs, creates, implements, conducts, and analyzes relevant Phase I-III clinical studies in collaboration with clinical operations, global drug safety, CMC, regulatory, data management, program management and others.
- Authors medical monitoring plans and collaborates with global drug safety and outside CROP vendors to review all safety data, and performs case assessment as needed.
- Directs interactions with the Clinical Operations Lead such that CMC, manufacturing, and clinical drug supply availability are fully integrated into the global development program.
- Leads clinical programs and studies including the product development plan, target product profiles, major deliverable prioritization and sequencing, risks and mitigations, and target vs actual tracking (budget and timeliness).
- Ensures appropriate objectives and resources are deployed to meet strategic portfolio plans and delivers on key milestones to advance all indications within the relevant program.
- Holds primary responsibility for integrating current best practices for clinical trial designs into the clinical development program.
- Supervises the creation and implementation of relevant project management activities related to individual studies and ensembles studies for any given indication and overall clinical program sequencing.
- Develops, authors, submits and presents scientific content at target conferences and journals.
- Maintains understanding of competitors and clinical developments by attending scientific meetings and tracking literature.
- Participates in relevant senior management program reviews and Board of Director level presentations on program status, timelines, and overall program architecture when appropriate.
- Invents and creates opportunities, and takes appropriate risks in support of business growth and advancement.
- Approaches communication with authenticity and the willingness and ability to articulate his/her beliefs.
- Uses influence to affect dynamic, and builds consensus to common goals.
- An MD from an accredited US or foreign medical school is required.
- Must have at least 10-12 years of post-graduate experience, which shall include at least five years of progressive experience in the pharmaceutical or biotech industry in clinical research and development or related fields.
- An excellent medical, science and technical background is required.
- Must have experience in management of clinical trials.
- Requires the ability to interpret and discuss data with senior management and key external stakeholders.
- Must have knowledge of all aspects of the drug development process and possess proven leadership abilities in working with broad cross-functional teams with matrixed reporting lines.
- Excellent oral communication skills, particularly in influencing and teaching is required.
- Must have superior organizational skills.
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.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.