Immuno-Oncology Medical Director / Clinical Development Lead
We are looking for a motivated, independent, rigorous and flexible hands-on Clinician who will thrive in a fast-paced dynamic environment. The successful candidate will be part of the expanding Clinical Development team and will contribute to the establishment of early clinical programs by collaborating with colleagues in the US, France and China, as well as with external partners.
The successful candidate will oversee the direction, planning, strategic development, writing execution, and interpretation of clinical trials/research and the data collection activities. This individual will work with the growing Clinical organization to formulate clinical development plans across programs. This individual will be responsible for providing input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations to the highest scientific standards. Based on experience, this individual will also be the primary Medical Monitor for clinical studies conducted under his/her responsibility and contribute to or provide medical review, analysis, and interpretation of data from clinical studies. The role will also be part of the establishment and build-out of the Clinical organization and play an instrumental role in leading the Clinical Research team while building a dynamic, performance culture.
Responsibilities Include but Are Not Limited To:
- Accountable for the medical scientific development and execution of clinical protocols.
- Accountable for the medical scientific aspects of implementing and conducting clinical trials (e.g., investigator meeting presentations, safety and medical monitoring, presentations at internal and external scientific meetings).
- Establishes consistent process and procedures for developing and implementing clinical trial study protocols.
- Provides medical input on clinical trial design and management of strategies for obtaining clinical evidence, including strategies for clinical trials for US, EU and/or rest of world registration studies as determined by business priorities.
- Implements and executes the final clinical trial strategy, clinical trial protocol development and clinical trial reports for registration studies.
- Drives innovation and excellence in the development of biomarker driven clinical development programs, which may include companion diagnostics.
- Collaborates with Clinical and CRO staff on clinical, scientific, and regulatory documents related to study deliverables including medical and scientific content of clinical study reports, and review of both clinical and analytical sections for regulatory submissions.
- Serves as the lead medical representative for Clinical Sciences & Study Management on the clinical trial team.
- Develops productive collaborations with thought leaders and scientists, internally and externally. Represents the medical and scientific excellence of the company in a positive and competent manner.
- Has and maintains scientific, technical and clinical expertise in oncology especially with respect to immuno-oncology.
- Reviews pertinent literature, prepares white papers/manuscripts, and provides education to staff as needed.
- Provides scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Ensures clinical data meets all necessary regulatory standards and activities are conducted in compliance with current applicable regulations, laws and guidance. This includes but is not limited to US, EU and China regulations as well as with HiFiBiO’s policies and procedures.
- Provides tactical/scientific mentorship, and direct supervision to other clinical staff as the company scales.
- Advanced medical degree is preferred (e.g., MD or equivalent). PharmD or PhD with extraordinary background and training may be considered.
- Board certification in Oncology or Immuno-oncology is desirable. Depending on education, minimum 2-11 years of clinical research experience in the conduct of clinical trials is desired, preferably in immuno-oncology or oncology.
- Experience in an industry/biotech setting as well as experience working in or closely with medical safety/pharmacovigilance teams are desirable, as is a working knowledge of clinical regulatory requirements.
- Proficient knowledge of medical and clinical trial terminology
- Excellent oral (including presentation) and written communication skills, including medical writing
- Strong organizational, computer dbase, time and project management skills with proven ability to plan and track deliverables and timelines
- Ability to work well in an international matrix environment
- Ability to prioritize and adapt to the changing needs of the business
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring, dose review, and independent response adjudication review committees with internal and external partners
- 20% Domestic and international travel may be necessary
Please include a CV and cover letter addressed to Tracy Smith, VP Human Resources at HiFiBiO Therapeutics. All CVs will be reviewed at our earliest availability.