Actym Therapeutics is a clinical-stage, Series A biotechnology company, based in Berkeley, CA. We have engineered a new drug modality harnessing the power of a genetically modified bacterial vehicle that safely introduces therapeutic payloads to activate the immune response in the tumor microenvironment. To achieve targeted anti-tumor effects, we have developed a systemically administered treatment that exploits intrinsic TME-specific metabolites, enabling selective enrichment of the bacterial vehicle in tumors. After cell-specific entry, our lead candidate, ACTM-838, positively activates tumor-resident myeloid cells and delivers two synergistic payloads, optimized IL-15 and STING, unlocking a comprehensive and durable innate and adaptive anti-tumor immune response. With the ability to tailor our platform utilizing a range of payload combinations, we aim to achieve a new level of therapeutic impact for cancer patients across multiple tumor types.
We are seeking a Vice President/Senior Vice President of Clinical Development to lead the clinical development of ACTM-838. The successful candidate will be both hands-on and strategic, with responsibilities extending from medical monitoring to strategic planning. In addition, she/he will have a track record of designing and executing robust clinical studies, leadership in providing expert input in scientific discussions and proactive engagement in interactions with health authorities, regulatory bodies, and thought leaders. As a member of the executive management team, the person will be involved with asset and indication strategy and help assure that activities are executed within expected scope, budget, and timelines. This position will collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, scientists and key opinion leaders (KOLs), Board of Directors as well as internal groups outside of Clinical Development, including Research, Business Development, Legal, etc.
Essential Duties and Responsibilities:
- Oversee and manage all aspects of clinical development, including study design, protocol development, data analysis and interpretation.
- Ensure trials are conducted in compliance with regulatory standards and work collaboratively with cross-functional teams to achieve clinical objectives and milestones.
- Serve as a hands-on medical monitor, closely tracking and reporting on patient safety, treatment efficacy, and drug tolerability.
- Develop and implement comprehensive clinical development strategies for both mono therapy trials and combination trials, with a focus on innovation and efficiency.
- Provide medical leadership for internal and CRO cross-functional teams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
- Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
- Provide medical expertise and training, as required.
- Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
- Assume primary responsibility for the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
- Contribute to the writing of manuscripts and publications.
- Comply with Actym Therapeutics SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
- Assist in preparations of materials for Advisory Board meetings.
- Support a team of professionals responsible for the development of clinical research protocols, clinical study reports, and scientific publications. Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization.
- Be accountable to Management and the Board of Directors for all relevant timelines and deliverables for the Clinical Development Department.
- Medical Doctor (MD) or non-US equivalent of MD degree is required.
- A minimum of 10 years of experience in clinical development within the biotechnology or pharmaceutical industry; previous experience in immuno-oncology drug development is preferred.
- Proven ability to plan and conduct early phase clinical trials and deliver high-quality results within established timelines.
- Lead cross-functional teams (e.g. pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
- Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior regulatory filing experience required.
- Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
- Excellent leadership and team management skills.
- Strong strategic thinking, problem-solving, and decision-making skills.
- Excellent verbal and written communication skills.
- Ability to travel as needed to represent the company at various meetings and conferences.
- Demonstrated commitment to ethical standards and high levels of personal integrity.
The Ideal Candidate Shares Actym’s Core Values:
- Commitment: We are committed to bringing life-saving drugs to patients with cancer.
- Accountability: We are accountable to each other and accept responsibility for our actions.
- Quality: We are committed to the highest level of quality in our experiments, analyses, and communications with each other.
- Respectfulness. We are respectful of each other and the diverse backgrounds that we bring to the team.
- Decision making. Attuned to opportunity, we make intelligent decisions, adapting to create the best outcomes. We are decisive and undaunted by failure. We accept what doesn’t work, learn from it, and get on to what does.
- Collaboration. We achieve our goals together, inspiring, sharing, and creating as a team.
- We do the right thing.
Employee is expected to be on site in Berkeley regularly.
Actym offers comprehensive benefits including 401K, and generous health care coverage with Medical, Dental, Vision plans.