Department: Medical Affairs
Reports to: Chief Medical Officer
Location: Office US-based
Summary of job description:
Reporting into the Chief Medical Officer, the Medical Director will be responsible for assisting the CMO in implementing the CRC drug development strategy and will lead all aspects of individual drug programs. They will provide clinical input on clinical protocol development, regulatory issues, patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, and presentation of data at national and international meetings. This position will have a strong outward facing presence and will support investigator-related and investigator-initiated initiatives and assist in the site evaluation and selection process for clinical trials. The position will also have access to pre-clinical data and assist in the implementation of the biomarker strategy as well as interactions with strategic partners. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Partner with the business development team to evaluate novel targets and platforms in the immuno-oncology space;
- Help develop the clinical strategy and integrated development plan for their oncology program, and work cross-functionally to implement, manage, interpret and communicate the results of clinical trials;
- Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports;
- Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverables of clinical trials under his/her direct responsibility;
- Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials;
- Responsible for analysis of clinical data, including safety monitoring in collaboration with PV;
- Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and PIs;
- Organize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings;
- Support R&D management and the commercial team with input on clinical development issues related to their commercial plan, and support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities;
- Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs; and
- Travel, as needed, nationally and internationally.
- MD with Board Certification in Oncology or comparable training, and recognized expert within his/her field.
Experience and skill requirement:
- 1-5+ years of relevant clinical research experience with at least some in industry. Experience in the biopharmaceutical industry preferred; substantial experience working on industry-sponsored trials will be considered.
- Thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
- A demonstrated track record of success in your field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively.
- Excellent written and verbal communication skills to meet the needs of varied audiences.
- Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
- Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.
- Excellent analytical, problem-solving and strategic planning skills.
- Well organized with strong management, leadership, mentoring and motivational skills.
- Ability to work independently and thrive in a fast-paced environment.
- Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.