A publicly traded specialty global pharmaceutical company is seeking a Chief Medical Officer. Reporting to the Chief Executive Officer, this newly created position, provides the right “hands on” leader an opportunity to build a best in class clinical and medical function while making a significant impact on the future of the Company. The CMO’s principle job responsibility is the oversight and management of all clinical and medical related responsibilities including the New Drug Application (NDA) and associated clinical program for the Company’s phase III development asset.
- Minimum of 15 years of experience in a medical affairs organization.
- M.D. is required.
- Extensive clinical research experience, specifically conducting clinical trials and leading the execution of pivotal phase III trials and associated strategy.
- Experience and understanding of FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.
- Experience working with the FDA on the special protocol assessment process (SPA).
- Experience with clinical and NDA development experience with orphan drugs and securing orphan drug designation.
- Experience with SLEEP or Central Nervous System (CNS) is preferred but not required.
- Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise and pipeline products.
- A hands on-leader who is willing to be both a leader and a doer. Experience working with smaller teams and finite resources cross-functionally across the entire Company.
- Understanding of Medical Affairs activities and experience leading Medical Affairs function.
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%.
A dynamic biopharmaceutical company developing innovative drugs for metabolic diseases is looking for a Head of Scientific Communication to join their team. Reporting to the Chief Medical Officer, this professional is required to have 5-10 years of relevant experience in medical communications, publication planning, and/or medical writing in the pharmaceutical/biotech sector. The right candidate will have demonstrated experience of creating robust, compelling, and accurate scientific/medical content with an ability to collaborate in a highly matrixed environment. Strong understanding of clinical trial design and execution, statistical methods, and clinical trial data reporting requirements is a must.
- Location: Boston, MA USA or Lyon, France
- Travel: ~30% US and International
- Education: BA/BS in life or health sciences; Advanced degree (MS or doctoral: e.g., PharmD or PhD) preferred.
- Scientific expertise in the Metabolism/Endocrinology area is preferable.
- Certification as a Medical Publication Professional (CMPP) is highly desirable.
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 Region Head/Senior Director of Business Development, responsible for driving profitable sales growth within the client’s manufacturing network. This leadership position will manage a team of five to six business development professionals across multiple disciplines in contract development and manufacturing of drug substances and drug products. This is a key management role with direct reports, but a successful candidate must be able to be a “working manager” capable of handling complex contract negotiations and managing products and accounts throughout the life cycle to ensure profitability as well as strong top line growth.
- 15+ years of related experience and at least 5 years in a CDMO environment required.
- Financially capable of understanding price and cost drivers and manipulation thereof to win profitable business.
- Basic understanding of the small molecule drug development life cycle and regulatory environment from NCE’s (PI-Commercial) to generics.
- Basic understanding of the pharmaceutical supply chain (commercial).
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.
This role reports to the Chief Business Officer and is responsible for the coordination and execution of all alliance and advocacy strategies, programs and activities supporting the client’s mission, corporate objectives and company reputation across partners, patients, providers and key third-party organizations. The position will require strong scientific skills, especially in biology, to manage scientific discussions across multiple rare and ultra-rare disease areas. The position will have a key face to face role with representatives of partnering organizations and institutions both in the U.S. and abroad.
- 5+ years of business biotech and/or consulting experience.
- S. degree with advanced degree (Ph.D. in biomedical sciences) preferred.
- Experience in alliance management and patient advocacy a plus.
- Strong analytical and problem-solving skills.
- Previous consulting experience a plus.
- The ability to travel up to 30%.
- Demonstrated ability to engage effectively at all levels of the organization and be a strong contributing team member and collaborator.
THESE ARE ONLY OUR FEATURED CAREERS
CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES
Phone: (610) 725-0290
Fax: (610) 975-0291
Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Wayne, PA 19087