Head of Clinical Development/Sr. Medical Director will be responsible for the development and execution of a comprehensive clinical development strategy of all clinical assets from early to late-stage development and will lead all aspects of individual drug programs in collaboration with the clinical teams. As a member of the senior management team, the Head of Clinical Development/Sr. Medical Director provides medical and scientific expertise in assessments and decisions affecting the company’s clinical development programs. The Head of Clinical Development/Sr. Medical Director is expected to guide and develop the company’s team of clinical development and supported staff, consultants and advisors and collaboratively work with senior and functional leaders to ensure fully harmonized and integrated development strategies to advance and expand our portfolio of products in development. The Head of Clinical Development/Sr. Medical Director is expected to develop and maintain relationships with KOLs on global scale, represent Clinical Development internally to senior management, as well as externally to KOLs, Lead advisory board meetings, responsible for the oversight of scope, schedule , resources of the programs and for the recommendation of strategic context and priorities to senior management. 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. In addition, he or she will provide medical oversight to all Programs and will serve as sponsor medical monitor on sponsored clinical trials. This position will have a strong outward facing presence and will support investigator-initiated trials programs. This is an integral role in the provision of successful product development in support of Drug development efforts.
Head of Clinical Development/Sr. Medical Director is a physician, preferably Board-Certified. The ideal candidate will have history of clinical and translational research and some industry experience in Oncology. The medical director is knowledgeable of the actions of regulatory bodies, in particular the FDA, and has 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 andobjectives.
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.
Key Accountabilities
Be responsible for analysis of clinical data, including safety monitoring in collaboration with PV, and implement appropriate pharmacovigilance actions, if necessary.
Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions.
Assist in the review of Investigator-Initiated studies and in the identification of clinical sites.
Establish and maintain contact with external experts , opinion leaders and strategic partners in academia, government, and industry to advance our Image.
Provide medical insight into Advisory Board meetings, learning materials for internal and external use.
Present clinical data at relevant advisory board meetings and/or scientific meetings as needed. Assist in the development of publication plan for Oncology products in development.
Complete scientific reports, manuscripts, and other educational materials
Help to identify opportunities for data presentation and representation at national and
international meetings and conferences. Contribute to business development efforts.
Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities.
Partner with the business development team to evaluate novel targets and platforms in the immuno- oncology space.
Help cultivate and advance a clinical development strategy and integrated development plan for oncology program, design, biomarker, and implementation of Phase I-III clinical studies in the immuno-oncology space.
Serve as Medical Lead/Monitor, and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of ongoing clinical studies.
Drive and execute the clinical activities that lead to successful IND and NDA/MA filings for new cancer therapies.
Educational requirements
• M.D required.
• US Board certification, Board Eligibility, or specialist accreditation
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 Early development of Phase I-II industry-sponsored trials with Immunotherapy ( Cpis, Oncolytic viral therapy, will be considered
- This position requires complex scientific knowledge and development expertise to translate an asset into a medicine. This individual will secure information/data from multiple sources (laboratory, clinical data, regulatory, commercial) and work to integrate this information into global clinical development plan to address development needs.
- Thorough understanding of Phase I-III drug development with proven ability to plan clinical trials, deliver high quality results within established timelines including but not limited to: , study monitoring , data collection and analysis, database cleaning , database close and ability to communicate clinical/scientific data and generate clinical/scientific documents.
- Be responsible for Medical Data Reviews of ongoing studies ( corporate sponsored and/or Investigator-Initiated- Studies) working together with clinical operations.
- Possess a history of prior meaningful participation in regulatory submissions, preferably withCBER.
- 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 goalsand improve the lives of patients.
- Strong business acumen, including working knowledge of changing U.S. payer and provider landscape.
- Strong interpersonal, influencing, presentation, and communications skills (written and verbal) to effectively address all levels within an organization.
- Excellence in solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
- A team player; able to collaborate successfully with both internal and external colleagues.
- Excellent communication skills both written and oral, including strong presentation skills.
- The highest personal integrity; committed to ethics and scientific standards.
- High energy and absolute commitment to culture
- Strong analytical skills, comfort managing through ambiguity.
- Understanding and success in dealing with different cultures.
- Ability to manage competing priorities and projects, requiring an excellent ability to prioritize andmanage expectations.