FEATURED

CAREER OPPORTUNITIES

Utilizing a broad set of skills, the CFO will serve as a strategic partner and financial advisor to the Chief Executive Officer, other members of the senior management team and the Board of Directors to help craft the overall direction of the company. The CFO is responsible for the company’s balance sheet, capital structure, financial reporting, compliance, and risk management. The CFO will ensure that assigned functions (accounting, analysis and planning, audit, control, tax, technology, treasury, and corporate communications), have the resources and expertise to perform at a high level and meet the company’s growing needs. The CFO will work to enhance the finance function to support the business of today, while creating a finance organization and administrative capabilities that can scale as the business grows.

  • Strong professional reputation with at least 15 years’ experience in accounting and/or finance, with at least 5 years with a publicly traded pharmaceutical/biotechnology company.
  • Experience serving as the CFO of a publicly-traded company is preferred.
  • Experience providing Human Resource function oversight a plus.
  • Plays a significant leadership role in initiating, advising, negotiating, valuing, and critiquing financial arrangements the company might consider such as equity and debt financings.
  • Contributes significantly to the company’s growth by lending financial perspective and input to the evaluation of key strategic relationships such as mergers and acquisitions, licensing agreements, joint venture, and strategic alliances along with oversight over the relevant portions of any subsequent due-diligence processes.
  • Externally focused working closely with analysts, investors, banks and other constituents to communicate the company’s performance and strategy.

Our client is a privately held biopharmaceutical company focused on building a robust pipeline by advancing its proprietary late stage photodynamic therapy product. The Head of Regulatory Affairs will be responsible for managing regulatory submissions and conducting internal and external regulatory/clinical compliance audits in relation to FDA regulations. This role will be immersed in the development and implementation initiatives aimed at enhancing the commercial success of the company. He/She will represent the company at meetings with FDA or other government agencies and provide regulatory input into the selection of strategic product development targets for the Corporation.

  • Responsible and accountable for the strategic direction, leadership, growth, tactical and operational success of the company’s regulatory program and will act as Head of Worldwide Regulatory Affairs for the Company.
  • Develop and implement Global (primary focus on US and EU) regulatory strategies for the company and serve as the lead contact to the FDA and other health authorities.
  • Lead the preparation and submission of worldwide regulatory applications to the FDA / other health authorities (ex-US) supporting clinical development programs and marketing application filings.
  • Create, organize, review and lead the preparation of all pre-filing and pre-approval submissions in accordance with FDA regulations.
  • Filings/Reports include, but are not limited to, IND, CTA, BLA, MAA, annual reports, meeting packages, and other submissions/regulatory communications as required.
  • Review and develop a plan for existing and new draft regulatory guidelines, impact of regulatory trends, risk, as well as compliance requirements. Provide regulatory intelligence and advice on relevant new and existing regulatory strategies.
  • Lead and manage both internal and external Regulatory Affairs teams / vendors. Review current Regulatory Affairs structure and resources, determine and remedy any existing gaps, and develop regulatory SOPs for the company.

Our client, headquartered in San Francisco, California, is a digital health firm looking for a senior sales professional to create partnerships and commercials sales for their chronic disease management solutions into the major hospitals and ACOs / Home health agencies around the country. The ideal candidate will have a proven ability to successfully sell complex solutions to senior-level executives. This position requires an understanding of software-based technology and the healthcare / health system domain. The role is on an interim full-time basis with an opportunity for permanent hire with success.

  • Experience selling to health systems, ACOs, hospitals, home health agencies.
  • Ability to identify market segments with potential to use the solution and provide internal team with findings and opportunities.
  • Successfully sold new innovative software solutions to C-suite and senior executives.
  • Exceptional sales performance history that can be confirmed through references and documentation.
  • Proven experience in new business development.
  • Have run the entire sales process from prospect to closure.

 

This role will provide leadership for the regulatory and quality management requirements of the current and future needs of the business and its customers and the relevant regulatory authorities. The role is to ensure that the company follows all applicable global regulations in an efficient manner consistent with the company business model and that the Quality Management System (QMS) remains effective, developing a culture of quality first.

  • Minimum education: BS in technical or medical science.
  • Minimum of 15 years’ experience in the pharmaceutical clinical arena.
  • Possess thorough knowledge of GCP, Medical Devices, and regulations including FDA, EU Directives, ICH.
  • Lead regulatory inspections, e.g., FDA, MHRA and other competent authorities.

The VP, Business Development is responsible for evaluating external growth opportunities for our client and, where appropriate, executing transactions to access the assets of interest. This person will work closely with the global senior management team, as well as functional leads from R&D, Commercial/Strategic/Business Development, Finance, and Legal, to achieve these goals. This role will be a highly visible and critically important for the strategic growth of the company, and will contribute in growing revenues and capabilities by providing evaluations of products, markets, customers, and competitors. The VP of Business Development will identify and assess new product and/or M&A opportunities for the U.S. market and will be the U.S. lead in the negotiation of business deals and contracts with potential partners, in accordance with company guidelines.

  • At least 15 years of business/corporate development experience in the pharmaceutical/biotech industry.
  • Strong business and financial acumen, and experience with various deal structures (e.g. joint ventures, partnerships, M&A, etc.).
  • Strong market knowledge and network of relationships (people, companies, institutions, consultants).
  • Contemporary awareness of product in-licensing opportunities within rare diseases and the client’s areas of specialization.
  • Strong relationship-building skills and ability to interface with all levels of management and across multiple cultures.
  • Ability to assess short- and long-term market potential.

Oversees Facilities, Engineering, Metrology, and EHS, and coordinates external Workplace Services. Directs capital projects, technology transfer, manufacturing scale-up, and new technology implementation. Has authority to act as a delegate for the NASD Site General Manager, as well as all other Engineering, Facilities, and Operations positions. This role requires a bachelor’s degree (B. S.) or equivalent in engineering or related life sciences field with a minimum of ten years related experience; or equivalent combination of education/training and experience. Prior experience in cGMP compliant facility required.

  • Knowledge of cGMP guidelines, international and FDA regulations pertaining to the production of APIs and drug products.
  • Knowledge of manufacturing processes and methods for cost control, quality improvements, yield improvements, and manufacturing efficiency.
  • Knowledge of engineering requirements and codes for the design of equipment and process systems used in Biotech/Pharmaceutical GMP applications.
  • Knowledge of building codes, fire codes, electrical codes, Boulder code ordinances, and local covenants for GMP facility build-outs.

The Director, Business Development is responsible for scouting and evaluating external growth opportunities for the company and, where appropriate, executing transactions to access the assets of interest. This role serves as a member of the Senior Management Team and shares accountability with their management colleagues for leadership of the U.S. business. In this position, the Director of Business Development will identify and assess new product and/or M&A opportunities for the U.S. market and take an active role in the negotiation of business deals and contracts with potential partners, in accordance with company guidelines. This role is located in NJ, and reports directly to the U.S. General Manager and functionally to VP and Director Corporate Development.

  • At least 10 years of business development experience in the pharmaceutical/biotech industry.
  • Strong business and financial acumen, and experience with various deal structures (e.g. joint ventures, partnerships, M&A, etc.).
  • Strong market knowledge and network of relationships (people, companies, institutions, consultants).
  • General awareness of product in-licensing opportunities within rare diseases and the client’s areas of specialization.
  • Strong relationship-building skills and ability to interface with all levels of management and across 
multiple cultures.
  • Strong oral and written communication skills, advanced project management competencies, and track record of successful deal negotiations.

Oversees GMP Manufacturing and production planning, maintenance of manufacturing methods, processes, and operations for new and/or existing API products. Has authority to act as a delegate for the Director of Operations. The appropriate candidate will have a Bachelor’s Degree in a science related field (M.S. Preferred), a minimum of 10 years of Pharma production operations experience, and a minimum of 10 years of people management experience.

  • Knowledge of cGMP guidelines, international and FDA regulations pertaining to the production of APIs and drug products.
  • Knowledge of manufacturing processes and methods for cost-control, quality improvements, yield improvements and manufacturing efficiency.
  • Knowledge in the fields of science and engineering; and the ability to apply these concepts to define problems, collect data, establish facts, deal with concrete and abstract variables, draw valid conclusions, and represent the company in audits and client visits. Ability to apply technical knowledge, logic, and reasoning skills to risk assessments, problem analysis and resolution.
  • Technical knowledge of assays utilized for the testing of oligonucleotide APIs and raw materials.

Our client is the world’s leading provider of scientifically based, time-temperature indicators that alert if a medical product has been exposed to potentially damaging heat and/or freeze events. In this role, the Distribution Network Manager will have professional-level responsibility for driving market penetration and profitable growth coming from the company’s distribution network on both a domestic and international level.  This role reports directly to the Vice President, Global Customer Development.

  • Ability to work cross-culturally, in the Asia Pacific Region, Europe and South America.
  • Fluency (written and spoken) in Mandarin or Spanish.
  • Proven ability to identify and capitalize on international growth opportunities.
  • Skilled and demonstrated success in negotiation and achievement of results.
  • Experience and comfort in traveling internationally and working independently.
  • This role requires > 70% travel, which may include weekends, to attend customer visits, trade shows.
  • Bachelor’s degree in international business, marketing, or other business degree.
  • Six (6) to eight (8) years customer related professional experience in sales, business development, and distributor development.
  • Experience with “cold chain” distribution channels is preferred.

Responsible for the Pharmaceuticals Technology (PT) P&L, the Business Unit Leader will be actively involved in identifying new growth opportunities for the client’s PT business including internal development and acquisition of value-creating technologies. This business unit was recently established within the company. The Leader will support the development of an effective, proactive growth strategy for the client’s PT unit. He/she will implement the strategy with the objective of maximizing the value of the PT unit, leveraging PT technologies and products assets. The Leader will lead a team that identifies and evaluates new opportunities and structures relationships with pharmaceutical companies globally. He/she will coordinate and direct the team in generating new licensing opportunities, negotiating licensing and co-development agreements and promoting PT technologies and products to other pharmaceutical companies.

  • Bachelor of Science (MS or Ph.D. preferred) or related degree.
  • At least 10 years of experience in the pharmaceutical industry.
  • A proven capability to lead multinational teams and to grow revenues.
  • A successful record in business development activities, preferably in drug delivery or pharmaceutical technologies.

A global leader in the plasma protein biotherapeutics industry is looking for a Senior Medical Writer to lead the Medical Writing and Disclosure contributions for assigned clinical program(s). This position will drive and develop the messaging strategy within the therapeutic area to ensure effective communication (i.e. CDP, submissions, briefing books, risk management plans, responses to HA questions) underpins successful clinical development. The role will also critique ability of product strategy (e.g., submission plans) to deliver on business objectives or meet regulatory needs, and identify where new, additional or alternative arguments are needed.

  • A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization.
  • A solid understanding of the clinical development process, including the documents that are required at each stage.
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
  • Prior experience with submissions in Common Technical Document (CTD) format.
  • Degree in a scientific discipline.
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THESE ARE ONLY OUR FEATURED CAREERS

CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES

Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Suite 214
Wayne, PA 19087