About the role
The Executive Director of Clinical Development will have global responsibility for the preparation and implementation of Acepodia’s clinical development programs and pharmacovigilance. Working with the R&D team and relevant internal/external stakeholders to provide strategic guidance to maximize success of Acepodia’s programs.
The successful candidate will demonstrate the ability to work with internal stakeholders within Acepodia and engage with external stakeholders in the medical and scientific community and global regulatory authorities. In close partnership with Company’s senior management and all R&D functions, the Executive Director of Clinical Development will be responsible for the short and long-term clinical development strategy of Acepodia.
Education / Background
- MD, PharmD (US) or PhD degree is required with Scientific or Academia background in Oncology.
- Must have 10+ years of work experience in clinical development, including Phase I-III clinical trials.
- 3+ years of industry experience in cell therapy.
- Fluent in Mandarin is preferred.
Responsibilities include, but are not limited to
- Provide leadership to the Clinical Development team.
- Advance Phase I-III clinical programs from clinical study design and execution through interpretation of data and publication.
- Lead a team of translational scientists to develop hypothesis driven translational cell product-centric pharmacology, safety, and biomarker strategy.
- Serve as an expert leader and collaborate with internal research and external collaboration partners to identify key scientific questions for IND(s).
- Design and execute application of clinical biomarkers and companion diagnostic assays.
- Work Closely with CROs and key strategic alliance partners.
- Manage interface with external collaboration partners to design and conduct Proof of Concept (POC) studies.
- Develop and manage the Translational Medicines strategic plan and operating budget.
- Provide medical and strategic leadership for programs that integrate current knowledge in basic and clinical science from within Acepodia with that from the scientific community around the world.
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP).
- In conjunction with clinical operations, establish efficient clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
- Provide credible medical representation in the academic medical/scientific community.
- Represent Acepodia externally and build key relationships with the medical community, investigators, key opinion leaders, contract research organizations, regulatory authorities, and clinical sites.
- Ensure that the scope of work, planning, expectations, and project timelines are clearly communicated and aligned with clinical team and all key stakeholders.
- Conduct staff performance reviews and development planning for the clinical team and optimize clinical resources through recruitment and training of medical and scientific talent, as needed.
- Drive goal setting for clinical development in alignment with corporate goals.
- Prepare and monitor the clinical budget.
Position Requirements & Experience Relevant Skills & Experience:
- Relevant experience of pharmaceutical development in Cellular Immunology, Cell-Engineering in Oncology and clinical pharmacology preferred.
- An expert leader who brings extensive scientific and clinical knowledge in cell therapy and Immuno-Oncology.
- Senior level physician researcher with deep understanding and experience in cell therapy translational medicine, especially in Oncology.
- Strong strategic acumen, scientific understanding, and business clout to enable on-a-par interactions with C-level external collaboration partners and contacts in the industry and academia side.
- Willingness to embrace new ways of working in flexible and agile teams at the interface with
internal and external partners and alliances.
- Strong communication (oral, written) skills to present internally and at scientific meetings and author medical documents and scientific publications.
- Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies is preferred.
- Knowledge of medical management and oversight of clinical trials required (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
- Demonstrated experience and expertise in the primary authorship of clinical trial protocols and clinical study reports.
- Understanding of statistics and data management considerations for clinical trial design and scientific communications.
- Experience in obtaining global regulatory approvals and/or expertise in translational/early clinical development for innovative medicines preferred.
- High level of intellectual integrity and business accountability, as well as team spirit.
- Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills.
- Ability to collaborate with a diverse workforce within a cross-functional matrix environment, and travel internationally as needed.
- Fluent in English.
Contact Us to Apply
Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.