Director, Clinical Scientist (Respiratory indications)

Generate Biomedicines; Somerville (MA); Teletrabalho; USD 186 000 - 270 000; Tempo integral

Resumo da oferta

Generate:Biomedicines is seeking a Director, Clinical Scientist to lead late-stage respiratory programs (asthma and COPD) and to serve as the clinical science lead on cross-functional teams, driving protocol development, data analysis, and regulatory submissions.

The ideal candidate has an advanced degree and 9+ years in clinical development, with proven ability to design trials, interpret data, and collaborate across Regulatory, Biostatistics, and Safety to advance therapies to patients.

Qualificações

• Advanced degree and 9+ years of industry experience in clinical development, including direct experience in late-stage respiratory studies.
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP.
• Demonstrated ability to lead clinical science strategy and execution in late-stage trials.

Responsabilidades

• Lead as clinical science lead and core member of clinical development teams for respiratory studies (asthma and/or COPD).
• Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements.
• Develop and author clinical protocols, CSRs, and regulatory documents in collaboration with leaders.
• Participate in medical monitoring activities to ensure data quality and participant safety.
• Collaborate with cross-functional teams to ensure trial execution and regulatory readiness.
• Contribute to governance meetings with study updates, data summaries, and risk assessments.

Conhecimentos

Clinical development leadership

Late-stage trial design

Cross-functional collaboration

Data analysis

Regulatory documentation

Formação académica

Advanced degree (PhD/PharmD/MD/MS/PMP)

Descrição da oferta de emprego

The Role:

Generate:Biomedicines is seeking a highly motivated and experienced Director, Clinical Scientist to support the development of our respiratory programs, with a focus on asthma and COPD. This individual will serve as the clinical science lead on cross-functional study teams for Phase 2 and 3 trials, driving protocol development, data analysis, and regulatory documentation. The ideal candidate will bring deep expertise in late-stage clinical trial design and execution in respiratory indications, along with a proactive, solution-oriented mindset. The role will report to the Senior Director, Clinical Development.

Here's how you will contribute:

• Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
• Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
• Act as a key scientific contributor to late-stage protocols and regulatory submissions; Design and develop clinical trial protocols and associated documents (e.g. clinical study plans, data review plans, case report forms (CRFs), database design, statistical analysis plans) in collaboration with the clinical development leader and Drive development of clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
• Participate in medical monitoring activities: review and interpret clinical data on an ongoing basis in collaboration with cross-functional colleagues and external partners to ensure data quality, participant safety, and protocol compliance. Escalate issues as appropriate.
• Participate in site selection, initiation, and ongoing engagement; provide scientific support to investigators and address protocol-related inquiries
• Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight: track study progress against milestones and identify risks to timelines or data integrity, propose and help implement mitigation strategies, and serve as key scientific contact for CROs and vendors.
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
• Contribute to internal governance meetings (presenting or preparing study updates, data summaries, and key risks/issues)
• Ensure inspection readiness (maintain high-quality documentation and support audit/inspection activities).
• Support development and execution of publication plans, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)

Leadership Responsibilities:

• Take ownership of clinical execution and ensure accountability to high standards of quality and rigor
• Collaborate across functions with transparency and technical precision
• Foster an inclusive and high-performing team culture, offering mentorship and coaching where appropriate
• Communicate clearly and consistently, using data to inform decisions and recommendations
• Adapt readily to change and demonstrate resilience and curiosity in the face of ambiguity

The Ideal Candidate will have:

• Advanced degree (PhD, PharmD, MD, MS, PMP ) and 9+ years of industry experience in clinical development, including direct experience in late stage respiratory (asthma and/or COPD) studies
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP
• Demonstrated ability to lead clinical science strategy and execution in late-stage trials
• Excellent analytical, communication, and cross-functional collaboration skills
• Prior experience authoring clinical protocols, CSRs, and regulatory documents

Nice to Have (Optional):

• Experience with both small molecule and biologic modalities
• Familiarity with AI/ML-driven drug discovery platforms
• Previous involvement in BLA or MAA submissions

Location:

Somerville, MA / Andover, MA; remote (U.S.) optional with travel to HQ based on business needs.

About Generate Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

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.

Compensation:

The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Per Year Salary Range

$186,000—$270,000 USD