Executive Director, Early Clinical Research Physician - Cambridge, United States - Schrödinger

Description

Schrödinger Therapeutics Group is seeking a physician-scientist to serve as an Executive Director, Clinical Research working on novel oncology compounds in the early stages of development, from First-in-Human/Phase 1 until Proof of Concept. Schrödinger applies a proprietary physics-based drug design and optimization platform to advance assets into the clinic - making this a dynamic and fast-paced work environment.

The ideal candidate will be responsible for the development and execution of early-stage clinical programs as a member of the cross-functional asset development teams and leader of clinical study teams.

The Early Clinical Development (ECD) team supports drug development through clinical proof of concept and includes a cross-functional group of experts responsible for clinical sciences, clinical operations, regulatory sciences, regulatory operations, clinical quality, and medical writing. The Director of Early Clinical Research will have experience in oncology clinical drug development, clinical trial design, and execution, with a strong understanding of translational medicine and clinical biomarkers. This individual will play an essential role in a broad range of activities necessary to drive and manage critical strategic and operational aspects of a dynamic early clinical development team.
Who will love this job:

• Expert at gaining cross-functional alignment in order to advance molecules into the clinic and successfully execute on operational and scientific objectives in close collaboration with internal and external stakeholders.
• A highly motivated and experienced clinical research physician scientist with a strong background in oncology drug development and clinical trial design
• A savvy relationship builder who can work collaboratively with internal cross-functional teams and build partnerships with external partners, including key opinion leaders, investigators, and vendors.
• An excellent communicator with a strong work ethic who thrives in a dynamic, high-growth, entrepreneurial environment.
• A natural mentor with a proven ability to grow and develop talent.

What you will do:

• Provide medical leadership in the design and conduct early clinical Phase 1 and Proof-of-Concept development trials, assess clinical safety and efficacy data, and write clinical study reports, clinical sections of INDs, Investigator Brochures.
• Work closely with biomarker, drug safety, clinical operations translational research scientists. You will interpret reports, prepare oral and written results of product research, and participate in the discussion and prioritization of strategies formulated within the oncology and immunology disease areas
• Work collaboratively with the cross-functional compound development team on strategic planning, study design and execution of early-phase clinical trials, including protocol development, safety monitoring, and data analysis.
• Collaborate with translational sciences to validate potential biomarkers for patient selection and pharmacodynamic evaluation.
• Lead outreach and interactions with key opinion leaders, clinical investigators, and other key stakeholders to build relationships and ensure alignment on clinical development plans and clinical study execution.
• Provide medical oversight for clinical trials and ensure patient safety and ensure clinical trials are conducted in accordance with all relevant regulations and guidelines, including Good Clinical Practice (GCP).
• Contribute to clinical sections of regulatory submissions and represent Schrodinger at regulatory meetings.
• Participate in the review of preclinical data and support decision-making related to drug development.
• Stay current with emerging scientific and clinical developments in oncology and translational medicine.

What you should have:

• Strong background in strategy execution and project management with an ability to partner in the planning, development, and execution of scientific, regulatory and operational strategies.
• A high-performing physician-scientist familiar with clinical and translational research involving biomarkers and correlative laboratory clinical trial endpoints
• The ability to communicate effectively with basic laboratory scientists and clinical teams and alliance partners is critical.
• M.D./Ph.D. or a MD with a focus on oncology (preferably board-certified in medical oncology or hematology/oncology) with significant scientific research experience
• Minimum of 5 years of experience in early-phase clinical development of oncology drugs, including experience leading clinical research within the pharmaceutical industry or academia is preferred.
• Strong knowledge of clinical trial design and statistical analysis
• Experience interacting with regulatory agencies (FDA, EMA)
• Excellent communication skills, both written and verbal
• Ability to work collaboratively in a fast-paced, dynamic environment

Payand perks:

Schrödinger understands it's people that make a company great. Because of this, we're prepared to offer a competitive salary, equity-based compensation , and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain's New York Best Places to Work for the past three years running.

Estimated base salary range (NYC Only): $260,000 - $325,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.

Sound exciting? Apply today and join us

As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company's mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, "diversity" isn't just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn't mean better headlines or public images - it means increased adaptability and profitability.