(Senior) Director, Project Team Lead - Clinical

insitro; South San Francisco (CA); Hybrid; USD 210,000 - 275,000; Full time

Job summary

insitro is seeking a Senior Director, Project Team Lead for Clinical Development to lead drug development teams. This role involves overseeing the entire process from preclinical candidate nomination through Phase 1-2 clinical development, utilizing machine learning to enhance drug development. Candidates should possess a PhD or MD with extensive experience in clinical project leadership within the biotech or pharmaceutical industries.

Benefits

401(k) plan with employer matching

Medical, dental, and vision coverage

Paid parental leave

Quarterly budget for self-development

Support for attending professional conferences

New hire stipend for home office setup

Monthly stipend for cell phone & internet

Free onsite food and fitness center access

Free commuter transport options

Qualifications

• 8+ years of relevant experience for Director, 12+ years for Senior Director.
• Experience leading project teams in biotechnology or pharmaceuticals.
• Exposure to AI/ML methods is a plus.

Responsibilities

• Lead cross-functional drug development teams from candidate nomination through clinical development.
• Develop and implement clinical program plans with key stakeholders.
• Ensure alignment of drug development functions and address issues timely.

Skills

Cross-functional leadership

Strategic communication

Risk assessment

Collaboration with stakeholders

Interpersonal skills

Education

PhD or MD

Job description

The Opportunity

insitro is using machine learning to yield new, clinically actionable insights into critical unmet needs for patients. We aim to "go fast and improve things" across the entire drug development process from platform to pipeline to patients and back again.

The (Senior) Director, Project Team Lead (PTL, also called Asset Team Lead [ATL]) for Clinical Development is an opportunity to directly improve patients' lives by leading cross functional drug development teams from preclinical development candidate (DC) nomination through Phase 1-2 clinical development including proof-of-mechanism (POM) and proof-of-concept (POC). The PTL is accountable for an end-to-end, cross-functional, and effective integration of the therapeutic molecule strategy, timeline, and risk mitigation.

We are devoted to the effort to make clinical trials more helpful for patients and for drug developers. We believe that by focusing on what's best for patients, we can do what's best for drug development at the same time.

You will be at the forefront of designing and implementing innovative, accelerated approaches, and you will have the opportunity to utilize insitro's machine learning expertise to achieve drug development and clinical trial excellence.

You will report directly to the Chief Medical Officer. This role can be either onsite (3 days per week) in our South San Francisco office or hybrid (~1 week per month) in our office. Additional travel may be needed to relevant medical and health authorities.

This is an excellent opportunity for a seasoned PTL who is passionate about using their skills and experience to accelerate the drug development process and bring better drugs to the patients who can benefit most.

Responsibilities

In collaboration with cross-functional teams and working closely with Project and Portfolio Management:

• Cross-functional asset/program leadership is the key part of this role
• Develop and implement clinical program plans
  • Develop vision, strategy, and an end-to-end product plan that accounts for early uncertainties in first-in-human clinical development, define prospective, quantifiable endpoints for effective Go No Go decisions, enable the generation of a clinical data package that could support future registrational trial development and commercialization, and ensure there are adequate resources and technical expertise to meet strategic objectives
  • Identify and manage critical path activities and resources
  • Identify and manage interdependencies and hand-offs
  • Identify, classify, proactively mitigate, and document (as appropriate) potential risks and roadblocks, including likelihoods, severities, and key mitigations
  • Lead contingency planning
  • Capture and communicate progress; escalate potential delays with proposed solutions
• Direct clinical programs through insitro governance to ensure that:
  • Key drug development functions including preclinical, clinical, technical development/CMC and computational achieve strategic and operational alignment
  • Programs have adequate resources and technical expertise to meet strategic objectives
  • Issues are raised, discussed, and resolved in a timely manner
  • Program/project teams receive insitro Governance decisions in a timely manner
  • Programs adhere to agreed-upon scope, timelines, resources, and budget
• Communication and Culture
  • Accountable for clear and timely communication about the program throughout insitro such as via: agendas, minutes, all-hands and other communication methods
  • Responsible for facilitating Core Team meetings and working with Sub-team Leaders to ensure sub-teams and Core Teams are working in alignment on strategic and operational topics.
  • Present project updates, strategic issues, options, and recommendations to the insitro Governance Committees
  • Ensure clear and effective communication by each asset/project team by overseeing/reviewing presentations and documents to ensure clarity and effectiveness
  • Contribute to team culture and positively influence team environment that encourages authentic, clear communication and a "get stuff done" mentality

About You

• PhD or MD with 8 (Director) or 12+ (senior director) years (including doctoral or MD experience) of relevant experience and/or advanced education in life sciences, health-related field, or equivalent practical experience. Metabolic disease experience is very nice to have
• 5+ years of experience in clinical project/asset team leadership or equivalent role in biotechnology and/or pharmaceutical industries, directly as a PTL and in a leadership/management role to deliver therapeutic(s) and diagnostic biomarker(s) in at least one of our key therapeutic areas (metabolic disease, neurology/neurodegeneration, oncology) from FIH through proof-of-concept in the clinic to transition to late development to NDA/BLA submission.
• Capable of communicating and collaborating with people of diverse backgrounds and job functions, with a demonstrated a track record of collaborating with diverse stakeholders, including other clinical, translational, computational, and life scientists
• Strong interpersonal skills that motivate others to excel and achieve their very best
• Passion for providing better medicine to patients in need
• Exposure to AI/ML methods is very nice to have

#LI-Hybrid

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $210,000 - $275,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

In addition, insitro also provides our employees:

• 401(k) plan with employer matching for contributions
• Excellent medical, dental, and vision coverage as well as mental health and well-being support
• Paid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent (inclusive of birth, adoption, fostering, etc)
• Quarterly budget for books and online courses for self-development
• Support to attend professional conferences that are meaningful to your career growth and role's responsibilities
• New hire stipend for home office setup
• Monthly cell phone & internet stipend
• Access to free onsite baristas and cafe with daily lunch and breakfast for employees who are either onsite or hybrid
• Access to free onsite fitness center for employees who are either onsite or hybrid
• Access to a free commuter bus and ferry network that provides transport to and from our South San Francisco HQ from locations all around the Bay Area

insitro is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams–grounded in a wide range of expertise and life experiences–and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process.

About insitro

insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visitwww.insitro.com .

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