Medical Monitoring Director (Oncology MD)
PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor.
If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team. We are a diverse work family with a dynamic and earnest culture. We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer!
We are in the San Francisco bay area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants.
We are currently recruiting for a Medical Monitoring Director who will report to Vice President, Clinical Development, and continue advancing PACT Pharma’s cutting-edge engineered cell product. This will be a unique opportunity to see your contributions to PACT Pharma’s personalized process rapidly translate into the clinic and impact patient lives.
The ideal candidate should be aware of techniques in the latest molecular cloning techniques and in mammalian cell culture. The candidate should enjoy operating in an exceptionally dynamic and cooperative environment and will communicate results to and coordinate efforts with a larger cross-disciplinary team of immunologists, biologists, engineers, and bio-informaticians.
What You Will Do:
- Provide clinical oversight across all relevant studies and programs assumes a leadership role in ongoing clinical study team and relevant sub-team meetings, and clinical study communications internally and externally
- Design and develop clinical studies
- Serve as Medical Monitor on assigned PACT Pharma studies using the high-touch approach to work closely with site coordinators and PIs to manage patients on cell therapy studies
- Collaborate with the development of the product safety profile, clinical sections of the IB, and other materials
- Participate in the identification and selection of appropriate external investigators and sites
- Conduct ongoing reviews of medical/safety data, interim analysis, and reporting of data
- Responsible for any relevant abstract submissions, poster, oral presentations, and publications related to the assigned cell therapy product/indication(s)
- Represent PACT Pharma in key investigator and other external presentations, meetings, and other communications
- Play a lead role in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications, and other materials
- Work with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.
- Responsible to ensure that clinical development plans, objectives, and deliverables are consistently accomplished on time and on-target
- Lead and/or otherwise represent clinical development (CD) in sub-teams (e.g. Study Management Teams) relevant to assigned cell therapy product/indication(s) and helps ensure cross-functional integration, coordination, and alignment to enable effective and efficient CD plan execution
- Must have an M.D. and oncology/cell therapy experience is required
- 4 + years pharma/biotech industry experience OR an academic appointment in the field
- 5 + years experience with clinical trials. In-depth understanding of all phases of drug development
- Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred
- Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance
- Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations
- Familiar with competitive activity in the field
- Clinical leadership: is regarded as an expert in his/her field, is respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results
- Strong interpersonal, verbal communication, written and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
- Business presentation skills: effective at summarizing and presenting the key considerations and decision-points
- Ability to travel globally (20-30%)
- Academic/teaching background is a plus
- Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
- Experience publishing results of a clinical drug trial in a referred journal is preferred
- Previous people management experience is a plus
PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate based on race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.