Our client is a gene-editing and cellular therapy 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.
- In collaboration with the Clinical Operations lead, coordinates study activities in the program.
- Leads development of the Clinical Strategy/Clinical Development Plan and provides medical oversight into protocol development, data generation, and reporting.
- Applies expertise and advises on the execution of clinical partnerships, including developing strategy and performing diligence.
- Oversees Phase I-IV clinical development programs to ensure 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.
- Leads/participates in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with a clinical development program; Responsibilities may also include post marketing commitments and life cycle management initiatives.
- Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol.
- Co-leads product safety review committees as appropriate.
- Provides consultation on medical subjects to investigators and other company personnel, and applies medical knowledge to guide the safe, ethical, and efficient conduct of trials.
- Medical degree required.
- Must have subspecialty training in oncology/hematology and a minimum of 3 years academic and/or industry experience.
- Must have demonstrated potential or ability to design, initiate, and conduct clinical studies.
- Must have practiced in clinical study design, in academia and/or industry.
- Requires the proven ability to analyze and interpret efficacy and safety data relating to oncology is required. Requires ability to work across many interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.).
- Requires demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global matrix team environment.
- Must have strong and effective communication skills (written and verbal) and excellent medical/scientific writing skills.
- Personal ethical integrity and a commitment to improving the outcomes for patients with malignancies is required.
- Postgraduate training/certification/fellowship in drug development or in a medical discipline is highly 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 highly 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.