About Generate Biomedicines

Generate Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. Generate has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with over 275 employees.

The Role:

The Vice President of Clinical Development will be responsible for the strategy and execution of Generate's clinical trials. In support of these responsibilities, this leader will oversee the company's clinical directors and clinical operations staff, recruiting staff of appropriate experience to meet Generate's needs while remaining lean and nimble. They will be responsible for developing the infrastructure to conduct clinical research and data collection, and will collaborate closely with the Regulatory and Clinical Quantitative functions within Clinical Development, as well as with other departments at Generate, to conduct trials. They will interact with diverse external parties, including investigators and clinical sites, CROs and other consultants, experts in the field, scientific advisory boards and regulatory agencies. They will contribute to selection of targets and modalities for the pipeline, ensuring a smooth transition from preclinical to clinical development.

Here's how you will contribute:

• Build and lead the clinical research function, which includes clinical directors, clinical scientists and clinical operations.
• Plan for and direct internal and external resources to achieve company goals in a swift, high quality and compliant manner.
• Design and oversee clinical studies from Phase 1 through to registration. Know the details of each study and its participants and disseminate knowledge internally to enable decision-making.
• Identify and foster productive relationships with investigators, including key opinion leaders, participating in Generate clinical trials.
• Ensure smooth communication and collaboration between organizations and individuals involved in research at Generate, with particularly close attention to Preclinical Drug Discovery and the CMC/Quality organizations.
• Represent Generate externally at conferences and with other external parties such as partners, CROs, collaborators and investors.
• Dive deeply into the science being executed under their purview, staying abreast of the scientific literature; develop and disseminate well-informed opinions on the science as part of their leadership.
• Foster a safe, inclusive work environment. Support the personal and career development goals of their reports.

The Ideal Candidate will have:

• An M.D. degree with at least 10 years of experience in clinical practice and drug development. Drug development experience ideally includes experience in early drug development (e.g. testing of new compounds, dose selection and trouble-shooting) and at least one experience in participating in a registrational study with associated regulatory interactions. Medical Affairs experience alone is insufficient.
• A documented track record of leadership while in the pharmaceutical industry, recognized for leadership in their field.
• A patient-first attitude in trial design and execution.
• Experience in drug development in oncology is preferred but not required.
• Willingness to learn deeply about and develop drugs outside of their stated area of expertise.
• Experience in small and large companies is preferred but not required.
• A record of consistent professionalism, particularly when under pressure.
• A willingness to make thoughtful decisions swiftly with limited data.
• Strong organizational skills with an ability to work on multiple projects at various stages, concurrently.
• High standards for themselves, colleagues and reports. Willingness to have difficult conversations for the sake of advancing company strategy and patient well-being.
• Open-mindedness and creativity to new methods and bold strategies.

Location:

Remote.

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Generate Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generate Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster. The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations. The company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

Recruitment & Staffing Agencies: Generate Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate Biomedicines or its employees is strictly prohibited unless contacted directly by Generate Biomedicines's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate Biomedicines, and Generate will not owe any referral or other fees with respect thereto.