We employ high-energy team players who are both passionate about their work and compassionate for the patients we serve. We require innovative thinkers who enjoy rolling up their sleeves, thrive within a fast-moving environment and conduct themselves with the utmost integrity.

We offer competitive compensation, a comprehensive benefits package and a tremendous opportunity for advancement.

Click on our current openings below.

Job Summary: 

The Director of Financial Planning and Analysis will lead the company’s planning and analysis processes, including budgeting, sales forecasting, developing financial reporting packages for senior leadership, and business and valuation modeling. This position will interact with all levels of management across the organization. 

Key Responsibilities: 

  • Develop, implement and maintain an effective planning and analysis capability that will provide senior leadership with appropriate analytical tools to establish goals and measure performance of the Company’s businesses. 
  • Lead the development of the annual operating plan and budget process for the company and provide monthly update to P&L and cash flow forecasts. Build long-range plans. 
  • Routinely communicate business, financial and operational performance trends, historical and forecasted, using appropriate metrics. Suggest trends, resulting implications, key actions, and strategic implications. 
  • In collaboration with CEO and the commercial team, build ongoing forecasts of top-line revenue forecasts and develop a dashboard weekly that informs top management of sales against performance targets. 
  • Assist in the closing of the monthly accounting records by supporting the accounting team, as needed, in the analysis of accounts, primarily having to do with the tracking of contracts spend and progress. 
  • Attend monthly accrual meetings and track risks / opportunities against financial plans. 
  • Collaborate with the accounting department to perform monthly reviews of budget vs. actual with departmental managers. 
  • Develop a comprehensive monthly reporting package for senior management. 
  • Lead scenario modeling efforts for the development and growth of the company. 
  • Develop valuation models for business development deal and license opportunities. 
  • Prepare presentations in support of board meetings and investor presentations. 
  • Implement web-based financial forecasting software (BI360 or other). 
  • Develop and execute processes to allow for routine analytical reviews of company financial and operational performance, leveraging analytical resources and tools. 
  • Monitor performance and competitive dynamics of companies that are strategic partners and competitors. 
  • Develop case studies and evaluate metrics of those that have gone before us in the successful launch and market of orphan products. 
  • Assist business leaders in the negotiation of the financial aspects of certain service contracts. 

Position Qualifications: 

  • 10+ years of financial planning and analysis experience with progressive responsibility, especially with exposure to commercial operations and experience in biotechnology companies 
  • Knowledge of U.S. GAAP and technical pronouncements a plus 
  • B.S. degree in Business, Accounting or Finance is desirable, MBA preferred 
  • Strong PowerPoint and Excel skills 
  • Strong financial modeling skills required 
  • Knowledge of ERP systems may be helpful, but not essential 
  • Candidates should possess strong interpersonal, communication and organizational skills and have the ability to work with all levels of employees and be able to present findings to senior management 
  • Be able to meet the rigorous deadlines of a public company, multitask and prioritize responsibilities 
  • Be able to lead and direct staff when FP&A expands 

Company Overview:
Chiasma is a late stage Phase 3 biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is octreotide capsules for the orphan condition acromegaly and is currently in Phase 3 multinational clinical studies designed for both FDA and EMA commercial approval. Chiasma is a well-funded, public Delaware corporation (Nasdaq: CHMA) with wholly owned Israeli subsidiary.

SUMMARY:
Reporting to the Chief Executive Officer (CEO), The Head of Regulatory will be accountable for driving the regulatory strategy in collaboration with the senior management team and will be responsible for driving timely regulatory submissions and approach. This will include US and Global Regulatory Submissions, approaches to regulatory pathways and labeling. The Head of Regulatory will advise management on regulatory agencies with the CEO on behalf of Chiasma.

This position involves both high level strategic planning, interpersonal interactions with regulators, partners as well as hands-on responsibilities.

Responsibilities:

  • Develop US and global regulatory strategy aligned with Chiasma’s business objectives
  • Develop regulatory approaches, frameworks and pathways
  • Execute on the Chiasma regulatory strategy and activities
  • Provide guidance, direction and leadership on that strategy to the development to the development team and senior management
  • Build a global regulatory team that provides input into development, medical, and commercial teams
  • Provide strategic input to clinical development plans
  • Maintain up-to-date knowledge of US laws, regulations and guidelines as well as familiarity with the global regulatory environment
  • Act as primary liaison with all regulatory authorities via regulatory correspondence and leading regulatory meetings
  • Identify and coordinate with regulatory and experts and consultants
  • Author, review and edit regulatory submissions
  • Provide project plans and timelines for regulatory submissions
  • Drive timelines and deliverables related to submission documents
  • Understand electronic submission process and guide the development team in the preparation of electronic regulatory submissions and build the organizational infrastructure as needed
  • Author, and/or review edit documents i.e. informed consents, Investigator Brochures, study materials, essential documents, presentations, and reports as necessary
  • Advanced degree with a minimum of 15 years of industry experience and 8-10 years of direct experience as well as 5 years of experience in a senior regulatory role
  • Experience in the Endocrinology space preferred
  • Extensive experience understanding FDA guidance, new regulations/standards and submission of products for FDA review
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
  • Experience with orphan indications, breakthrough, and novel regulatory pathways to for an approval essential
  • Demonstrated leadership competencies in establishing clear direction and objectives, ability to simplify complex processes and foster an environment that brings out the best in people
  • Strong strategic and analytical abilities
  • Excellent verbal and communication skills

Chiasma Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.

Company Overview:
Chiasma is a late stage Phase 3 biopharmaceutical company focused on improving the lives of patients suffering from orphan diseases by developing and commercializing novel oral forms of therapies that are available today only by injection. The company’s lead product candidate is octreotide capsules for the orphan condition acromegaly and is currently in Phase 3 multinational clinical studies designed for both FDA and EMA commercial approval. Chiasma is a well-funded, public Delaware corporation (Nasdaq: CHMA) with wholly owned Israeli subsidiary.

SUMMARY:
The General Counsel will report directly to the Chief Executive Officer (CEO) is responsible for setting legal strategies and overseeing all legal matters for Chiasma to ensure the company is compliant with all applicable laws and regulations.

Responsibilities:

  • Develop functional plans for managing legal matters, including activities to be performed in-house or through outside counsel to best manage company’s legal activities and minimize risk for the business.
  • Manage and direct general corporate matters, including corporate organization, securities, law compliance, general transaction support, license agreements, employment law, regulatory matters, risk management, financing activities, and general contract management.
  • Ensure compliance with security regulations, corporate governance requirements and relevant legal and statutory requirements for corporate reporting of a public company. Co-lead the company’s disclosure committee with the CFO.
  • Draft, review, and negotiate a wide variety of agreements including confidentiality, material transfer, advisory board, market research, other intellectual property-related matters with domestic and international parties including clients, partners, vendors and users ranging from global life sciences organizations to healthcare organizations, research and clinical sites, landlords, subcontractors, and government agencies.
  • Provide leadership and technical guidance to ensure an effective global ethics and compliance program. Oversees the development of programs to prevent and detect violations of laws, company policies and other misconduct, promote ethical practices and ensure the implementation of the compliance program throughout the organization. Member of the Company’s to-be established promotional review committee and incentive compensation review committee.
  • Oversee legal matters pertaining to intellectual property strategy and management. Has legal responsibility for patent, copyright and intellectual property matters, Oversees negotiation andcompletion of agreements, confidentiality disclosures, material transfer, licensing agreements and other intellectual property matters.
  • Coordinates Board of Directors meetings and prepares meeting minutes and maintaining appropriate corporate records.
  • Address developments in the regulatory and governance environment and is proactive in areas related to compliance education and training. Monitors external developments in compliance, including laws and regulations, government investigations and industry best practices.
  • Provide oversight and leadership for all legal needs of the company across business functions.

QUALIFICATIONS:

JD from an accredited law school and admitted to practice In Massachusetts or other U.S. state

  • A minimum of 12 years of experience practicing law including both law firm and in-house experience of a public biotechnology company with a commercial product.
  • Broad legal experience covering multiple aspects of corporate law including business development, corporate contracting, intellectual property, employment and others within life sciences industry.
  • Broad experience with SEC and reporting Nasdaq compliance matters, including drafting 10-Ks, 10-Qs, 8-Ks, Proxy statements and Section 16 filings in collaboration with internal and external accounting and legal teams
  • Experience with FDA and healthcare regulatory and compliance are essential.
  • Demonstrated experience in commercial legal analysis and planning including effectively managing multiple projects/priorities.
  • Proven ability to make sound judgements and decisions. Possess the ability quickly assess problems/situations and provide effective solutions.
  • Strong organizational and time management skills in order to balance working on multiple projects in parallel.

Chiasma Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.

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