Contractor, Clinical Operations Associate Director

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. 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 $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

This is a 40 hour per week Contractor role with a term expected to end December 19th, 2025.   Open to Remote. We are offering $85-90 per hour for this Contract.

As an Associate Director of Clinical Operations, the qualified candidate will be excited about and capable of planning and executing early stage clinical trials (first in human including normal healthy volunteer studies, Phase 1 and Phase 2. The candidate will interface with internal and external stakeholders to plan, execute and problem solve before and during the life of clinical trials in several therapeutic areas (Oncology, Immunology and Infectious Diseases). The candidate will focus on site- and Contract Research Organization (CRO)-facing interactions to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical (including safety and efficacy) and translational data to support evaluation of the drugs under study. The candidate will be clear and efficient in communicating with cross-functional team members to achieve these goals. The candidate will serve as the clinical operations lead for at least one study in addition to leading a growing team of operations staff.

Here’s How You’ll Contribute

• Develop clinical operations strategy for each agent in development, either directly or by leading study staff depending on the stage of the agent
• Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical study reports, presentations, regulatory submissions and publications
• Evaluate external collaborators including Contract Research Organizations (CROs) and sites and select the best candidates for each needed function. Develop vendor scope of work, contract, quality, monitoring and budget.
• Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators. Ensure GCP compliance.
• Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered
• Develop and manage study timelines, working with internal partners (including but not limited to clinical development, clinical pharmacology and other quantitative functions, data management, biomarkers and translational, CMC, regulatory affairs and project management)
• Attend and, where appropriate, present at study site initiation meetings and study calls
• Patient recruitment planning and forecasting 

Qualifications:

• Associate Director level; Minimum 8 years of experience in clinical operations across at least 2 therapeutics areas.
• Experience managing CROs and vendors both in the US and in international clinical trials
• Experience serving as the clinical operations lead for one or more clinical programs
• Experience in site initiation visits, site management, data cuts for publication and regulatory requirements
• Understanding of the drug development process from IND to NDA
• Dedication to collaborative work in a fast-paced environment; open-mindedness to shifting strategy in a data-guided manner
• Ability to communicate effectively and efficiently and willingness to train other team-members within and outside of Clinical Operations
• Experience in large Pharma and biotech and with biomarker-selected studies preferred but not required
• Experience with at least one report is preferred, but a strong candidate with hands-on experience and a growth mindset will be considered

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 the Company’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 the Company will not owe any referral or other fees with respect thereto.

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