Vice President, Clinical Development

About Generate : Biomedicines

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

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. The Company 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 : Biomedicines was founded in 2018 by Flagship Pioneering and has received over $750 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 325 employees.

The Role :

The VP of Clinical Development will be responsible for the execution of Generate's clinical trials, and for program leadership of the lead program in immunology. In support of these responsibilities, this leader will oversee the company's clinical directors, clinical operations and safety 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 execute clinical trials, and will collaborate closely with the Regulatory and Clinical Quantitative functions within Clinical Drug 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. The VP of Clinical Development will report into the SVP of Clinical Drug Development.

Here's how you will contribute :

• Build and lead the clinical research function, which includes clinical directors, clinical scientists and clinical operations.
• Serve as program lead for Generate's late stage immunology asset or assets.
• Hands-on involvement in planning and execution of Generate's clinical trials.
• 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.
• Deep knowledge of therapeutic areas under study, including emerging data in the field.
• 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.
• Foster a safe, inclusive work environment. Support the personal and career development goals of their reports.

The Ideal Candidate will have :

Location :

This role will be based out of our headquarters in Somerville, MA. We are able to consider remote US based talent for this position.

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.

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