Reporting to the President, Head of Clinical Development will be responsible for assisting in the implementation of our drug development strategy and will lead all aspects of individual drug programs. He or she will provide clinical input on clinical protocol development, regulatory issues and patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, as well as presentation of data at national and international meetings. This position will have a strong outward facing presence and will support investigator-initiated trials and assist in the protocol review, site evaluation and selection process for clinical trials. The role functions internally as a medical expert/monitor to support the development and execution of an efficient and integrated global medical/scientific strategy including scientific evidence generation and scientific information exchange with key stakeholders.
The Head of Clinical Development is a Physican, preferably Board Certified. The ideal candidate will have history of clinical research or some industry experience in Oncology. The Medical Director is knowledgable of the actions of regulatory bodies, in particular the FDA, and has the experience in all aspects of clinical trials. The ideal candidate should have significant experience in their medical specialty and would thrive on proactively engaging internal and external leaders and will serve as a medical expert for their compound(s) and/or disease area. He or she will have strong commercial aptitude and/or experience, including proven ability to translate and appropriately align commercial and scientific goals and objectives. S/he will have solid peer relationships with external scientific and clinical experts in Oncology. 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.
- Help cultivate and advance a clinical development strategy and integrated development plan for the oncology program, design, biomarker and implementation of Phase I-III clinical studies in the immuno-oncology space.
- Serve and 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.
- Be responsible for analysis of clinical data, including safety monitoring in collaboration with the PV, and implement appropriate pharmacovigilance actions if necessary.
- Provide medical insight into Advisory Board meetings, learning materials for internal and external use.
- Assist in the development of publication plan for oncology products in development.
- Complete scientific reports, manuscripts and other educational materials.
- Work with investigators to identify publication and abstract opportunities.
- Help to identify opportunities for data presentation and representation at national and international meeting and conferences.
- Provide oversight for internal review of manuscripts and data presentations.
- Contribute to business development efforts.
- Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities.
- Partner with business development team to evaluate novel targets and platforms in the immuno-oncology space.
- M.D. Required
- Board certification, Board eligibility or specialist accreditation in medical oncology
Experience and skill requirement:
- 2-5+ years of relevant clinical research experience in Oncology clinical development and/or medical affairs. Experience in the biopharmaceutical industry preferred; substantial experience working on industry-sponsored trials with immunotherapy will be considered.
- Thorough understanding of Phase I-II drug development with proven ability to plan 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/EMEA requirements, good clinical practices and pharmaceutical clinical development.
- Closely interface with Clinical Ops and early development groups to define opportunities and explore new areas of scientific discovery.
- Support R&D Management and the business development team with input on clinical development issues related to their BD plan, and support the business development process by providing medical expertise for in-or out-licensing, partnering and acquisition activities.
- Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs CTAs, investigator brochure, CRFs, annual IND reports, CSRs, ISSs, ISEs, and clinical export reports.
- Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverable of clinical trials under his/her direct responsibility.
- Develop and maintain relationships and serve as the main medical liaison with KOLs and PIs.
- Organize and present at relevant clinical advisory boards and or medical/scientific meetings as needed.
- Develop and/or review clinical trial protocols and serve as the medical lead for trial conduct.
- Assist in the review of investigator-initiated studies and in the identification of clinical sites.
- Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies and outside audiences, and publish results if research projects.
for consideration, please email cover and letter and CV to firstname.lastname@example.org