A clinical-stage biopharmaceutical company focused on targeted treatments for cancer is in need of a Chief Financial Officer (CFO). 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.
- An undergraduate degree is required, preferably in accounting, finance, or a scientific field. An MBA or other advanced degree and/or CPA is preferable, but not required.
- A 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.
- Hands on experience with public company reporting, SEC regulatory issues and NASDAQ listing requirements.
- Current knowledge of accounting, SEC and corporate governance issues and regulations.
- The company is headquartered in North Jersey.
Our client, an early stage biopharmaceutical company discovering, developing and commercializing drugs containing cannabinoids, is in need of an interim Chief Financial Officer to work 3 – 5 days per week. This is an interim-to-hire position for the right candidate. This position will be based in Langhorne, PA., and will report to the CEO located in CA.
- Has been CFO in a publicly traded company within the last 5 years.
- Has helped a public company raise money on the public markets.
- Strong GAAP knowledge.
- Experience with SEC filings.
- Bachelor’s Degree in accounting.
- Advanced Degree and/or CPA highly preferred.
- Minimum of 10 years of strategic financial experience is required.
- Minimum of 5 years of progressive management experience.
- Recent experience in the Life Sciences required.
A biopharmaceutical company is looking for a VP/SVP Global Head of Regulatory. The position will head all of Regulatory Affairs activities worldwide for the company and its portfolio. The role will be responsible to ensure timely registration with worldwide Regulatory agencies, in particular in the US, EU and Japan, as well as to develop competitive regulatory strategies of each asset. Based in the Burlington office (Boston area), this role reports to the Chief Medical Officer (CMO).
- Minimum of 10-15 years’ professional experience in the biotechnology/pharmaceutical environment in the development of biological and pharmaceutical
- Minimum 7 years’ senior-level experience interacting with competent authorities, in particular with the FDA, EMA and
- Strong knowledge of the Regulatory environment in the US, EU, and
- Extensive leadership, management and project management experience in the multiple facets of drug regulatory affairs and drug
- The candidate will have a M.D. or Ph.D. or similar advanced degree in relevant scientific field (e.g. pharmacology, molecular biology).
- Fluency in English, both written and oral. Preference will be given to candidates with familiarity with French and/or Japanese.
- Travel: ~30% US and International.
A biopharmaceutical company developing phospholipid drug conjugates (PDCs) is looking for a Vice President Medical to join their team. The ideal candidate will have a mastery of the drug development process (especially early development, PK, DMPK, ADME, and early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. This role will oversee the design and implementation of early stage pre-clinical and clinical projects. He/she will ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Highly independent role; able to make decisions with minimal consultation.
- M.D. with drug development experience is required.
- Clinical or research experience (in a pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology is required.
- Chemotherapeutic/cytotoxin experience is preferred.
- Experience and desire with driving patient recruitment a must.
- Ability to travel 25-30%.
Our client has developed proprietary diagnostics designed for the early detection of colorectal cancer. Reporting to the CEO, the Interim Head of Project Management provides internal direction, leadership and accountability for pipeline projects. This role has the opportunity to become a full-time permanent position for the right individual.
- Undergraduate degree: BA or BS in business or finance required. Master’s Degree preferred.
- Background in pharmacy, biology or other life science required.
- Ideally 10+ years of experience working in diagnostics, pharma, biotech and/or medical device in roles that routinely required influencing and directing multiple projects and responsibilities.
- Excellent communication skills with the ability to interface effectively with senior management, interdisciplinary project teams, subordinates and external vendors.
- Project management certification desired (PMP certified).
Reporting to the SVP Global Regulatory Affairs and Quality & Compliance, the Interim Director, Global Regulatory Affairs will be responsible for providing global strategic and operational excellence, leading innovative and ambitious development solutions, and partnering cross- functionally with a sense of urgency, resilience, and energy to meet the unmet medical needs of patients. The incumbent will be the primary point of contact with global regulatory health authorities and will partner with the Quality & Compliance team to ensure compliance and quality in all regulatory communications, submissions, and processes. The incumbent will work closely with the SVP in this highly visible role to build a team and culture that aligns with the values of the organization and focuses on bringing safe, effective, and innovative therapies to patients with unmet medical needs and drive success in executing corporate strategies and goals.
- Bachelor’s and master’s degree in a scientific discipline required, Pharm.D., or Ph.D.
- 10-15 years of global regulatory affairs with proven experience in developing global strategy, operations, and
- Prior experience and a successful track record within the biotechnology and pharmaceutical industry in successful submission of INDs, CTAs, Meeting documents, and accelerated pathway
- Experience working in a fast-paced, matrixed
- Office located in Blue Bell, PA.
Our client is looking for an Interim Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) to work in their Blue Bell, PA office. Reporting to the Head of Global Regulatory Affairs, the incumbent will have a critical role in the department with responsibility for all CMC-related strategy, development, and oversight supporting the corporate objectives. The incumbent will partner closely with senior leadership in Pharmaceutical Science, Global Regulatory Affairs, Quality & Compliance, and other key functional areas, as well as external partners and Contract Manufacturing Organizations (CMO), to drive successful global regulatory development and registration strategies for all assets.
- Bachelor of Science degree in a physical science required; Masters or other advanced degree is preferred.
- Minimum of 10 years’ experience working in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents including IMPD, IND, NDA, and attending regulatory meetings with health authorities including the FDA and the EMA.
- Demonstrated experience partnering with Pharmaceutical Science personnel and other functions to support, address, and/or solve critical challenges facing the regulatory CMC function.
- Experience working and leading in a matrix environment.
- Experience working in both large pharmaceutical and small biotechnology organizations.
- Previous experience and responsibility supporting technology transfer of small molecule active pharmaceutical ingredient and drug product from one CMO to another.
- Experience participating in an inspection by the FDA and/or EMA.
- Broad familiarization and knowledge of GxP requirements including: GMPs, GDocP, GDistP, and GCPs.
- Experience working on and supporting global clinical development programs; rare disease experience a plus.
A rare disease company is looking for a Regulatory Affairs Leader to lead and manage the regulatory functions and activities related to new and existing products, on a domestic and/or international basis as required by the Company and its affiliates. Ensures the implementation of the registration strategies for the Company, in line with business objectives and priorities and in compliance with regulatory requirements. Supports efforts to obtain world-wide approvals to market our products. Operates as a key stakeholder in the Company’s regulatory activities and initiatives accountable to ensure the quality of the Company’s records, products and processes. Participates as a key member of project teams responsible for lifecycle management and pipeline development programs.
- Bachelor’s degree or equivalent required; advanced degree in the life sciences strongly preferred.
- Must have at least ten (10) years of experience in Regulatory Affairs, with at least two (2) years of experience working with Regulatory strategy.
- Demonstrated experience and expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA, Scientific Advice), NDAs, and other major regulatory submissions.
- Experience in a commercial-stage organization required.
- Prior experience with outsourced functions and managing contract employees preferred.
- Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.
- This position is based in Lebanon, NJ.
- Limited travel; approximately 20% on average; depending on business need.
A clinical-stage rare disease biopharmaceutical company is looking for a Therapeutic Team Lead who will be responsible for the ‘hands on’ development and implementation of clinical development activities. Reporting to the COO, the Team Lead will provide leadership and policy direction to ensure the company meets and/or exceeds organizational goals. The successful candidate will provide strategic and tactical oversight, medical input, advice and key opinion leader interaction, concerning: Project planning for clinical trials and development programs, protocol development and review and medical review of ongoing trials. Requirements include a demonstrated understanding of, and the ability to interpret, GCP/FDA standards/guidelines, as well as a clear understanding of internal/external resource management. The selected candidate will possess a strong desire to work in an innovative, emerging growth company environment.
- Ideal candidate will have an M.D., Ph.D., M.S., PharmD and/or MBA.
- 7+ years of pharmaceutical/biotech experience in clinical drug development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
- Clinical experience in rare diseases or therapeutic areas of interest preferred.
- Strong working knowledge of the FDA and other regulatory organizations.
- Strong working knowledge of GCPs, principles of ICH GCP, roles of the IRB/IEC sponsor/investigator, preparation of the clinical trial protocol, IB and clinical modules for FDA regulatory approvals.
- Ability and desire to work collaboratively with senior scientific and business leaders to execute on near- and long-term plans, and to adapt to rapidly changing business conditions.
- Ability to manage multiple clinical trials at different stages in several programs as required.
- Experience in preparing and reviewing documents for clinical development, including the coordination, review and sign-off processes to ensure high-quality document submissions to IRBs, health authorities and regulators.
A global specialty pharmaceutical company is looking for an interim professional to support commercialization of their generic product(s). This a relatively small part of the client’s business that they’d like to expand. The ideal candidate will lock in initial contacts and support initial bids with wholesalers. This Interim will manage existing customers (price, orders, etc.), develop and implement strategies to expand customer basis, and lead price and agreement negotiations. This role is also responsible for long- and short-term revenue forecasts, supporting profitability/pricing and financial analysis, and attending main trade and customers’ events.
- Extensive experience with commercialization of generic products (U.S.).
- Excellent knowledge of U.S. generic market (Wholesalers, GPOs, PBM, etc.).
- Good commercial network (Customers and Payors).
- Ability to work autonomously.
- Knowledge of financial analysis.
- Ability to work and interact with CFO and CEO.
- 40 hours/week, can be remotely based. Some travel required.
A life sciences company with over 35 years of active pharmaceutical ingredient development and manufacturing expertise is looking for a Director, Business Development, who will report to the Regional Team Leader. This role is responsible for sales growth of custom development in the assigned territory by targeting new and existing customers to secure contract manufacturing opportunities, contributing new business development opportunities from customer interactions to the portfolio development team. He/She will develop and maintain customer relationships to ensure a good network to provide the basis for future contract manufacturing agreements. He/she will be the main customer interface at assigned accounts and will be responsible for communication between customer and the technical teams at our manufacturing sites. He/she will also be responsible for preparing proposals in response to customer RFPs by coordinating the necessary input like costs calculations and timelines from site functions.
- Degree in Chemistry, Pharmacy, or Business Administration.
- 15-20 years of experience in sales and business development or key account management in the custom manufacturing (CMO) market.
- Proven network in the relevant territory; preferable contacts to the sourcing organization of the top 50 pharma companies.
- Extensive experience in all aspects of Supplier Relationship Management.
- Experience with retaining and growing existing customer relationships and closing new accounts.
- Strong understanding of customer and market dynamics and requirements.
- Willingness to travel and work in a global team of professionals.
Reporting to the Chief Medical Officer, the Medical Director will be responsible for the ‘hands on’ development and implementation of clinical development activities. The Medical Director will provide leadership and policy direction to ensure the client meets and/or exceeds organizational goals. The successful candidate will provide strategic and tactical oversight, medical input, advice and key opinion leader interaction, concerning: Project planning for clinical trials and development programs, protocol development and review and medical review of ongoing trials.
- Requirements include a demonstrated understanding of, and the ability to interpret, GCP/FDA standards/guidelines, as well as a clear understanding of internal/external resource management. The selected candidate will possess a strong desire to work in an innovative, emerging growth company environment.
- M.D. Board certified with relevant clinical experience in areas related to client programs.
- 7+ plus years of pharmaceutical/biotech experience in clinical drug development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
- Clinical experience in rare diseases or therapeutic areas of interest preferred.
A global leader in the plasma protein biotherapeutics industry is looking for a Principal Medical Writer. This is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency. This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions.
- Post-graduate qualifications (Ph.D. or M.D. preferred).
- A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organisation.
- A minimum of 3 years in a supervisory role.
- A comprehensive understanding of the clinical development process, including the documents that are required at each stage.
- A comprehensive understanding of medical writing processes, standards and issues.
- Submissions in Common Technical Document (CTD) format.
- Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
A global leader in the plasma protein biotherapeutics industry is looking for two Senior Medical Writers to lead the Medical Writing and Disclosure contributions to assigned clinical program(s). These roles are responsible for driving and developing 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. He or she will be required to 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. These roles will align, coordinate and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).
- Bachelor’s Degree in a scientific discipline required (Ph.D. or M.D. a plus).
- 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.
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CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES
Phone: (610) 725-0290
Fax: (610) 975-0291
Ashton Tweed, Ltd.
314 S. Henderson Rd.
King of Prussia, PA 19406