Senior/Medical Director
1 week ago
Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.
We are seeking a Senior/Medical Director who will support clinical and medical assets by the successful execution of clinical development programs and deliverables in partnership across the organization; with external academicians and collaboration partners.
As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The Senior/Medical Directorwill play a key role the establishment and growth of clinical research functions to assure best-in-class global capabilities and execution. Accountabilities include clinical support for the development and implementation all Precigen sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA). Senior/Medical Directorplays a critical role in the medical monitoring of a clinical study ensuring safety to patients. This role will work synergistically and cross functionally (in a matrix environment) with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, and translational research.
DUTIES AND RESPONSIBILITIES:
- Responsible for ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines.
- Partner with clinical operations and other cross-functional teams for the successful implementation and execution of clinical studies.
- Provide expert clinical input to influence the study design via collaboration with primary investigators, key opinion leaders, study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
- Closely follow medical developments within assigned areas, including cell therapy for oncology, and disseminate new information within Clinical Team and wider organization, to transform trends and emerging data into agile clinical plans
- Participate or lead as needed the review and assessment of new opportunities
- Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with the different functional departments to ensure cross functional input into protocols.
- Support the development of clinical components of regulatory submission documents for instances where marketing approval is warranted.
- Lead development and delivery of the clinical study report
- Work cross functionally in the preparation of launch & branding materials and publications.
- Create clinical study or program-related slide decks for internal and external use.
- Identify continuous process improvement opportunities.
- Identify incremental organizational resource needs - staff, budget, and systems.
- MD, within a clinical and/ scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
- 5+ years' experience in oncology and cell therapy, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials.
- Demonstrated experience and success within other biotech/pharmaceutical companies.
- Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one program through to a licensing application.
- Possesses general knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
- Expert understanding of global clinical study design and drug development process.
- High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
- Knowledge of GCP and ICH Guidelines.
- Flexibility to work with colleagues in a global setting.
- Able to engage in work-related travel approximately 20% of time.
- Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
- Experience with the development and support of related SOPs and policies is expected.
- Knowledge of industry standard Clinical Development IT solutions expected.
- Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects
- Maintains a high degree of understanding and awareness of new and emerging clinical developments to impact specific studies and clinical development plans.
- Strong leadership skills with the ability to influence others and drive consensus building
- Shows greater independence in the development of options for study design and development of the statistical analysis plans
- Executive presence; confident, positive attitude, enthusiastic and charismatic.
- Value based collaborator - respectful, accountable and collaborative.
- Self-motivated and independently minded.
- Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Impactful written and verbal scientific communication.
- Problem solving and risk-mitigation skills.
- Appreciation of diversity and multiculturalism.
- Strategic and creative thinker.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
- Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.
EOE MFDV
Precigen, Inc. is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies to target the most urgent and intractable challenges in immuno-oncology, autoimmune disorders and infectious diseases. We invite you to discover more at www.precigen.com.
#LI-ONSITE #LI-AZ1
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