Medical Director or Senior Medical Director
Company
Synlogic is bringing the transformative potential of synthetic biology to medicine. We are building the premier Synthetic Biology platform to engineer bacterial Synthetic Biotic medicines which benefit patients in new ways
Using a platform that leverages reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways.
Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria and Enteric Hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology.
We combine Human Logic and Science Logic to drive meaningful work, careers, and life at Synlogic. We foster a people-focused environment grounded in: Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire: Innovation, Integrity, High Performance, and life -changing Results.
We continue to build and enhance our organization. This position is best suited for professionals who are comfortable working in a growing and adaptable, biotech environment.
If you want to challenge yourself and build your career while bringing the transformative potential of synthetic biology to patients then we'd love to hear from you.
Job Summary
Synlogic is seeking a Medical Director / Senior Medical Director to fill a key strategic leadership role at Synlogic.
The successful applicant will be accountable for the creation and execution of clinical development plans, which ultimately lead to the approval of novel Synthetic Biotic Medicines for patients. Working closely with clinical operations colleagues, and with cross-functional teams, and external partners, the Medical Director will oversee the strategic direction of 1 - 2 metabolic disease programs at Synlogic. The role will encompass providing advice and direction to pre-clinical teams, and owning clinical development for a portfolio of programs from early- to late-stage development.As befits a small entrepreneurial environment, the role will be accountable for all aspects of the clinical development activities for the assigned program(s), from working on clinical strategy to providing medical monitoring oversight.
The selected candidate will have a deep understanding of clinical development with experience in Ph1-Ph3 development programs.He/she will be a creative clinical scientist with strong collaboration skills and a passion for changing patient lives.
Responsibilities
- Accountable for the clinical development strategy for rare or less common metabolic disease program(s), as part of an integrated cross-functional team
- Responsible for developing and executing clinical plans including the design of clinical studies, preparation of regulatory documents, assessment of risk-benefit
- Engages external patient advocacy organizations, KOLs, PIs and clinical sites to support the development of clinical strategies and the execution of clinical studies
- Leads internal and external resources to develop and execute the clinical plans, developing and inspiring others to deliver to patients
- Champions the patient perspective within Synlogic and with external partners
- Accountable for all clinical development activities for the assigned program(s) from clinical development plan design, through KOL interactions, to medical monitoring
Skills and Experience
The successful candidate will be an experienced medical director with a track record of successfully advancing programs to patients.
- MD with clinical experience required. Experience in metabolic diseases desirable. Specialty training in nephrology and a track record of scientific publications are a plus
- Clinical development experience in Phase 1 - 2 essential and Phase 3+ desirable. Experience in rare disease clinical development a plus.
- Successful track record of developing and executing clinical development strategies and plans, regulatory documents, based on deep understanding of drug development process including technical, business and regulatory issues
- Strong cross-functional collaboration skills, including strong communication skills, ability to work well with others and lead individuals and teams
- Highly accountable, driven, positive attitude
- Strong ability to manage and deliver multiple projects or priorities
- Excited by our vision, mission and platform
Behaviors
We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results. Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.
Synlogic is committed to creating a diverse and inclusive environment and is proud to be an equal opportunity employer, embracing diversity in all forms.Synlogic hires, trains, compensates and promotes talented Synlogicians regardless of age, color, disability, gender, gender identity or expression, genetics, national origin, race, religion, sexual orientation, veteran status, and other protected statuses as required by the laws and cultures of the geographies in which we operate.We believe in lifting others both inside and outside of the company, ensuring all of our community has access to opportunities and innovative therapies.
Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting. Our compassion for each other creates a safe environment for continuous risk taking and personal development - facilitating a rapidly moving, fast-paced environment. We connect with our colleagues by having fun together.
We take our work seriously and value integrity in producing the highest quality work. We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team.We encourage openness, direct feedback and transparency in decision-making to enable an inclusive, nimble environment.
We seek individuals who exemplify these behaviors and who encourage others to do the same.