The Medical Director (Clinical Oncology) will be a key member of the clinical team who will be accountable and responsible for the planning, executing and study design protocol development, implementation and monitoring of the company’s Immuno-oncology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and will be responsible for the compliance of the department and the company to regulatory standards and procedures.
This highly motivated, experienced physician will closely partner with and report to the CMO to lead one or more clinical trials with protocol implementation, medical oversight of trials, conduct and reporting including clinical input to cross-functional trial teams and regulatory interactions. The position has high visibility with internal leadership team and external stakeholders and will serve as subject matter expert on clinical and medical strategic initiatives.
Essential Duties & Responsibilities:
- Assist in or design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents.
- Discuss study design with investigators and key opinion leaders.
- Provide clinical input for clinical protocol monitoring guidelines and analysis plans.
- Drive clinical interpretation of study data. Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur.
- Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling).
- Serve as medical lead on one or more clinical studies for medical input into study feasibility, site selection and site initiations; assessing patient eligibility and issues related to protocol conduct
- Oversee and lead medical monitoring activities and subject safety including serving as primary medical contact for study physicians and sites
- Physician representative on regulatory and pharmacovigilance teams to provide input and safety strategy across studies
- Lead or assist in the development of publications - abstracts, manuscripts, slides, etc.
- In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status.
- Assist in database finalization, reviews of study results, results interpretation and CSR’s.
- Assist in planning and presentation conduct of investigator meetings and Advisory Boards.
- Assist with field site questions during conduct of trials as needed.
- Present study results, as appropriate, to medical/scientific community at meetings and in published format.
- Other Corporate Initiatives: Assist with other key marketing and communication initiatives and perform other duties as assigned.
- MD with 4-8 years’ clinical development experience in the pharmaceutical or biotechnology industry and relevant therapeutic specialty clinical practice in Oncology and/or Hematology (board certification or eligibility in Oncology or Hematology is desirable)
- Experienced with clinical phase I-III of pharmaceutical or biotech product (esp. experience with immuno-oncology development)
- Experienced strict guidelines that include IND/NDH, GCP/ICH and similar
- Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts
- Strong written and verbal communication skills (fluency in written and verbal English) as well as proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
- Strong work ethic with expectation of excellence from self and others. Must have high personal credibility and outstanding written communication skills
- Adaptable, flexible, independent and resourceful with ability to roll up sleeves and multi-task in order to thrive and lead in smaller and growing company environments
- Self-starter who works with a sense of urgency and functions as a strong team player effectively working with other disciplines
- Willingness to travel as needed to support a variety of Company initiatives
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Email resumes to firstname.lastname@example.org. Please reference Job ID: Medical Director
Apexigen is an equal opportunity employer