What if…you could join an organization that creates, resources, and builds life sciences companies that invent breakthrough technologies in order to transform health care and sustainability?

 Since Flagship’s founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.  

 Position Summary:

The Assoc. Director is an important team member in creating, growing, and building Pioneering Medicines, a new unit within Flagship.  Pioneering Medicines is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients. We are creating a portfolio of novel medicines by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases that are beyond their current focus. Pioneering Medicine is also working to combine these platforms in unprecedented ways creating novel treatment options.  Through this approach, Pioneering Medicines seeks to deliver the benefits from Flagship’s platforms to more patients, faster.

The Assoc. Director reports to the SVP, Portfolio Strategy and Operations.  He/she is accountable for the operational efforts of our preclinical programs.  The Assoc. Director is responsible for managing the operational aspects of discovery, preclinical, and IND activities to support candidate nomination and IND filings and to rapidly enable First‑-In-Human (FIH) studies and proof-of-concept trials.  The Assoc. Director will play a key role in setting up our operational model, selecting outsourced partners, and ensuring that critical preclinical activities are completed on time and within budget.

Flagship is an experiment in institutional, entrepreneurial innovation practiced in the context of a small company with an insurgent mindset.  We are seeking individuals with an entrepreneurial spirit, strong communication skills, and comfort working in and contributing to a dynamic and cross-functional team environment.  The level of the role will be commensurate with the education and years of experience of the identified candidate.

Key Responsibilities:

▪ Provide strategic input into our preclinical operating model and selection of CRO partners to ensure access to the right services, in the time when they are needed, and at the most efficient cost

▪ Working with Research, oversee operation aspects of pre-clinical studies (GLP and non-GLP) for inclusion in IND submissions, including ADME/DMPK, biodistribution, safety pharmacology and toxicology studies

▪ Work with discovery and development colleagues to develop detailed timelines and responsibilities for the conduct of IND/CTA-enabling studies/activities

▪ Manage projects conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, completion of contract milestones, and study close-out

▪ Oversee the management of consultants and contract research organizations (CROs) to support pre-clinical & clinical development programs

▪ Ensure completion of preclinical studies to support project timelines and goals. Relentlessly ensure the execution of critical activities for project teams

▪ Work with other stake holders on establishing and forecasting the preclinical budget.  Establish and adhere to the preclinical budget.

▪ Present program updates to team members and leadership

Minimum Qualifications:

▪ PhD or Master’s degree. 5+ years of drug development experience or scientific, functional experience at a minimum.

▪ Highly experienced in managing preclinical operations

▪ Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding

▪ Extensive knowledge of the scope and extent of Pharmacology, ADME, Toxicology and CMC studies/activities required to optimally conduct first-in-human studies and rapidly transition to POC studies. Deep knowledge of GLP, GCP and ICH regulations

▪ Experience with preparing INDs and CTAs

▪ Strong leadership competencies and management experience, including selecting CROs and overseeing the relationship

▪ Hands-on experience establishing and maintaining budgets for preclinical or nonclinical activities in support of pipeline assets

▪ Significant experience on biologics and / or RNA based therapies and gene therapy, is a plus

▪ Extremely resourceful and effective in highly uncertain circumstances

▪ Effectively utilizes information technology systems and project management tools and systems

▪ Demonstrated ability to work well with others within and across functions/teams

▪ Strong communication skills both written and verbal; skilled in writing project documentation; able to foster open communication; possesses good conflict resolution skills


Values and Behaviors

▪ Great sense of urgency

 ▪ Entrepreneurial spirit

▪ Mission oriented and dedicated to bringing breakthrough therapies to patients

▪ Fosters a growth oriented, high energy, and encouraging environment

▪ Ability to hold oneself and others accountable for commitments in an assertive and positive manner

More About Flagship Pioneering

We are creative optimists and we would love for you to consider joining our team!  See all our open opportunities across Flagship Pioneering’s Ecosystem!

Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $34 billion in aggregate value. To date, Flagship is backed by more than $4.4 billion of aggregate capital commitments, of which over $1.9 billion has been deployed toward the founding and growth of its pioneering companies alongside more than $10 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including:  Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO),  Foghorn Therapeutics, Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Syros Pharmaceuticals (NASDAQ: SYRS).

 

We believe pioneering is best done by teams, and that it is a process that can be taught, learned, and replicated.  Learn more about our Company Creation Model.

Can Breakthrough Innovations Be Made Systematically? A Conversation With Noubar Afeyan, Flagship Pioneering’s CEO.

Recruitment & Staffing Agencies:  Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates.  The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team.   Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

 

 

 

 

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