Our client is a biotechnology company. They have asked us to assist them in their search for a Medical Director.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Provides leadership and coordination with multiple research functions on key clinical efforts.
- Collaborates with the Clinical Operations lead to coordinate study activities in the program.
- Acts as the lead development of the Clinical Strategy/Clinical Development Plan and offers medical oversight into protocol advancement, data formation, and reporting.
- Applies expertise and advise on the execution of clinical partnerships, including developing strategy and performing diligence.
- Superintends Phases I-IV of the clinical development programs to guarantee that regulatory requirements and quality standards are met.
- Strives to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures.
- Acts as a company representative in interactions with external scientific leaders and regulatory authorities.
- Searches and analyzes medical literature, writes/reviews abstracts, manuscripts, etc., for publications and/or presentation at internal/external meetings.
- Leads/participates in investigator meetings and advisory committee meetings.
- Runs/partakes in strategic evaluation and feedback into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with a clinical development program.
- Assimilates preclinical information (pharmacology, toxicology, pharmacokinetics) and deciphers the implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol.
- Acts as the co-manager for the product safety review committees as fitting.
- Provides consultation on medical subjects to investigators and other company personnel.
- Applies medical knowledge to guide safe, ethical, and efficient conduct of trials.
- Must have a medical degree or equivalent.
- Must have training experience in oncology/hematology.
- Requires a minimum of 3 years academic and/or industry experience.
- Must have a demonstrated potential or ability to design, initiate, and conduct clinical studies.
- Must have previously practiced in clinical study design, in academia and/or in the industry.
- Requires a proven ability to analyze and interpret efficacy and safety data relating to oncology.
- Must be able to work across a variety of interfaces.
- Must have demonstrated strong interpersonal skills.
- Must have the ability to influence, and to function in a global matrix team environment.
- Requires strong and effective communication skills (written and verbal), as well as excellent medical/scientific writing skills.
- Requires personal ethical integrity, as well as a commitment to improving the outcomes for patients with malignancies.
- Postgraduate training/certification/fellowship in drug development or in a medical discipline is preferred.
- Experience in regulatory interactions throughout the different phases of development is highly preferred.
- Experience and solid understanding of drug developing strategy and process is preferred.
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.