Synlogic’s initial pipeline includes Synthetic Biotic medicines for the treatment of rare genetic metabolic disorders such as Phenylketonuria (PKU) and enteric hyperoxaluria, which may lead to renal complications. In addition, the company is leveraging the broad potential of its platform to create Synthetic Biotic medicines for the treatment of other diseases, such as inflammatory bowel disease, other inflammatory and immune disorders, and cancer.
Every day we work tirelessly to deliver on 4 aspirations:
People: LIVING each day with passion for building up and building out our Synlogic team
Platform: Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
Products: Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
Promise: Building our company to launch multiple novel LIVING medicines – mastering a new frontier in medicine
We continue to build and enhance our organization. If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you.
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 are at our best when we blend Human Logic and Science Logic to build great teams and promote a great culture.
Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization. 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. 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 trust and maintain the nimbleness of the group.
Depending on experience the candidate will act as Medical Monitor in the ongoing clinical studies with the potential to grow into a clinical program lead role. This is an excellent opportunity for an MD new to drug development to learn quickly and be introduced to all aspects of clinical drug development. For someone with prior experience this role offers a highly visible clinical leadership role. As an integral part of our team, you will provide scientific leadership to the metabolic clinical trial programs while collaborating across our matrixed network of highly skilled physicians and scientists, patients, and external stakeholders. This person will be involved in the translational clinical activities across a growing, early-stage portfolio with a strong focus on kidney health. Providing therapeutic area expertise and revolutionizing trial design with a curious innovative, and inspiring approach, you will play a pivotal role in transitioning discovery research into clinical practice. The successful candidate will bring proven leadership skills and a strong background in clinical or academic research. This position reports to the Therapeutic Area Lead, Metabolic Diseases.
HOW WILL YOU CONTRIBUTE:
- Provide leadership and medical expertise in the development and execution of clinical programs, including protocol writing. Lead and matrix-manage high performing study teams, collaborating across the organization.
- Drive and deliver all aspects of clinical trial execution in the role of Medical Monitor in collaboration with Clinical Operations from study concept to final reporting.
- Support timely and high-quality analysis, interpretation, and communication of data in ongoing and completed studies.
- Work closely with the Translational Biology group and project teams to incorporate the therapeutic directions and patient selection strategies into clinical protocols.
- Author and review regulatory documentation and other communications, including IND, IB, annual reports, CSR, abstracts, manuscripts, and presentations.
- Coordinate relationships with external key opinion leaders and investigators and lead/participate in investigator meetings, advisory boards, and site visits.
- Work and partner with internal and external (CRO, investigator) stakeholders.
- Provide clinical and scientific input to clinical development strategies/plans for novel drug candidates as part of a cross-functional project team.
- Establish best practices and embrace our values-based culture.
- Adhere to and implement quality standards and SOPs in clinical development.
WHAT YOU CAN OFFER:
- MD or equivalent with post-graduate training in a relevant specialty required
- Experience in nephrology, gastroenterology, or genetic medicine is a plus
- Experience in drug development not necessary but 1-2 years of experience in pharmaceutical industry is preferred
- Effective oral and written communication and presentation skills
- Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential
- Creative problem-solving skills, ‘out-of-the-box’ mindset
- Excellent planning, prioritization, and organizational skills
- Demonstrated leadership ability and well-developed interpersonal skills. A proven track record of successfully interacting with and influencing a wide range of people; building strong positive relationships
- Ability to work in a fast-paced, dynamic, passionate, team-oriented environment
- Ability to travel up to 20%