career opportunity

Job Opportunity: Deputy Editor, HD Insights

Job description: If you are passionate about HD research and want to reach nearly 3,000 HD researchers and clinicians around the world, consider joining our team as the Deputy Editor of HD Insights.

Oversee the creation of 3-4 editions per year of HD Insights. Responsible for soliciting, editing, and coordinating review and layout of each edition, as well as contributing original articles and ideas for the publication. Ideal candidates will have experience in academic writing, be familiar with Huntington disease research and have the flexibility to work remotely with individuals all over the world. Training and supervision will be provided remotely by the outgoing Deputy Editor and current Editor. Ideal start date is Q2 of 2017. Compensated position.

Please send CV and letter of interest to editor@hdinsights.org.

Career Opportunity: Vice President, Global Specialty Development, NDD, Teva

teva_cns_logoVice President, Global Specialty Development, NDD

The Role

The Vice President, Global Clinical Development, NDD will report directly to the Vice President, Global Head, NDD/MDS & Clinical Research Innovation within the global R&D function, overseeing the clinical development of Huntington’s Disease. This is a critical role within the company, having a significant impact in defining the clinical development strategy at a high level.

The outstanding individual sought will need to be of the highest caliber medically and scientifically, with exceptional leadership capacity and interpersonal skills and the ability to work in a dynamic and truly global company that is growing rapidly. This means flexibility, taking initiative, thinking “on the fly”; a desire to be very hands-on, decisive, and self-assured are critical.

More specifically, the Vice President will be responsible for providing scientific/medical leadership and support for Huntington’s disease products now going into phase III development programs as well as looking to develop the early pipeline. There are several regulatory filings on the horizon; this individual will provide leadership and guidance throughout the process. With the addition of several new DRUG/COMPOUNDS to the NDD pipeline, the visibility of the portfolio has been elevated and the new Vice President will be a very important part of the company’s near and long-term future.

Close collaboration with Key Opinion Leaders in the Huntington’s disease market and with Teva’s Commercial and Medical Affairs groups will be critical. The new Vice President will have significant leadership responsibilities, s/he will have be an essential member of the senior management team to develop the overall strategy for the franchise and provide scientific leadership to motivate, retain and develop the group.

The clinical development department is highly team-oriented. Trust and respect is paramount, voicing opinions and thinking outside the box in a professional and appropriate scientific/medical manner is encouraged. Decisions are made as a team and the group’s culture is one that understands there is no “only” way to do things. Hard work and critical thinking are highly valued and expected. The NDD/MDS franchise is critically important to the success of Teva as a whole.

Key responsibilities include:

  • Lead and develop the Huntington’s disease clinical development program for compounds in late phase global clinical development. This includes direct oversight and management of the clinical development trials and compounds.
  • Responsible for developing the overall clinical strategy for the Huntington’s disease franchise and provide medical and scientific support to current and future commercialized products.
  • Responsible for Global Clinical Development Phase II/III trial activities and in protocol development, study execution and interpretation of results.
  • Close collaboration with Teva Global Medical Affairs and strong relationships with Key Opinion Leaders in the Huntington’s disease space.
  • Help develop the commercial strategy for compounds in late phase clinical development and attend sales meetings and other commercial meetings/activities as needed.
  • Interface effectively with other Clinical Development functions and other departments, including Clinical Operations, Biometrics in design and conduct of the clinical programs.
  • Work closely with Marketing, Medical Affairs, Regulatory Affairs and Pharmacovigilance in development of clinical plans that meet both regulatory and commercial needs.
  • Highly important member of the Vice President’s management team; makes go/no go decisions on the pipeline and key decision maker in what the company does in Huntington’s Disease in the present and future.
  • Create and maintain a positive and productive work environment and exhibit exceptional leadership capabilities by creating trust and respect within Huntington’s Disease clinical development as with other colleagues in Teva.
  • Need to support critical evaluations and recommendations of business development opportunities in the respiratory area working with colleagues from the Search and Evaluation Team and business development.

Candidate Profile

The ideal candidate will demonstrate the following qualifications and competencies:

  • M.D., Board Certified (Neurology, Psychiatry, etc.) or Clinical Geneticist with Strong Clinical Knowledge of Huntington’s disease. (Neuroscientist or Neurology or Psychiatry.) Minimum of 10 years’ experience in a clinical development function within a biotech or pharmaceutical company.
  • Outstanding proven track record in Huntington’s disease drug development; intimate understanding of Huntington’s disease a must.
  • Experience filing multiple New Drug Applications (NDA’s) preferred.
  • Strong relationships with Huntington’s disease Key Opinion Leaders (KOL’s) across the country and globe.
  • Well-developed leadership skills with the ability to influence, able to make decisions and stand by them. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility walking in the door.
  • Exceptionally sharp thinker; ability to push innovation and creative thinking. Strategic thinking, accountable and forward-looking; able to see larger business picture.
  • Flexible, work in a fast-paced environment and be open to change or the unknown.
  • Collaborative and proactive, with a hands-on, roll-up-the-sleeves style and attitude.
  • Excellent interpersonal, presentation and communication skills.
  • If interested, please call/send CV to:

Al DiPalo
Sr. Strategic Sourcing Partner
Teva Pharmaceuticals
267-619-2132
Mauro.dipalo@tevapharm.com

Career Opportunity: Director/Sr. Director Global Specialty Development, Neurodegenerative Diseases, Teva

teva_cns_logoDirector/Sr. Director Global Specialty Development, Neurodegenerative Diseases

The Role

The Director/Sr. Director is responsible for the development, execution and management of multiple clinical programs worldwide across all phases of clinical research in the areas of Neurodegenerative Diseases (NDD). Reporting to the VP, Global Head of NDD Clinical Development, the Director/Sr. Director will oversee clinical study teams, represent the clinical development department in functional area teams, and will be responsible for leading cross-functional teams in a matrix environment.

The individual is expected to be able to function independently in the daily management of clinical research projects including the preparation/review of related key documents (i.e. protocols, Investigator’s Brochures, clinical study reports, summaries for regulatory submissions). He/she will be the point person for all clinical questions (e.g. methods, safety) that arise on specific protocols and programs under his/her responsibility.

Key responsibilities include:

  • The Director/Sr. Director will responsible for the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development in this regard.
  • The Director/ Sr. Director will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Director/Sr. Director will engage in scientific interactions foster relationships with opinion leaders in the field of migraine and headaches.
  • Will be a core member of the Global Project Team
  • Will have and maintain the expertise necessary for the clinical development of the product
  • Prepares and manages multiple Clinical Development Plans
  • Leads or oversees the cross-functional clinical development team
  • Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion
  • Makes presentations at the Investigator Meetings and other relevant internal or external
  • Responsible for identifying human resources requirements to implement the Clinical Development Plan
  • Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement with the clinical supplies group
  • Ensures clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures
  • Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigliance, VP Clinical Research and the Head of the Global Respiratory Therapeutic Area as needed.
  • Oversees the preparation of documents for IND/NDA/MAA and other regulatory documents
  • May lead an NDA/MAA submission team independently, as needed
  • Partners cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, GCO, and GCPR in the execution of Clinical Development Plans
  • Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing
  • Responsible for authoring protocol synopses and working with Medical Writing. Provides input and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant clinical documents
  • Author and/or review abstracts, posters and manuscripts, present data at scientific meetings, as needed
  • Represent Teva at Scientific meetings, advisory boards, KOL boards and meetings with regulatory agencies, as needed

Candidate Profile

  • MD, DO or equivalent combination of education and related work experience. PhD, PharmD with strong proven track record will be considered
  • At least 3 years’ experience in a pharmaceutical industry environment or related area planning/managing clinical trials, with proven ability to manage projects and/or lead project teams effectively. MD/DO without prior industry experience but with relevant knowledge and expertise in clinical trials will be considered
  • Experience in neurodegenerative disease, movement disorders, rare diseases (CNS) therapeutic areas is strongly preferred (Huntington’s Disease, Parkinson’s disease, Alzheimer’s disease, Motor Neuron Disease/ALS)
  • Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks, 2-4 years of managerial experience preferred
  • Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast-paced, multi-tasking environment

If interested, please call/send CV to:

Al DiPalo
Sr. Strategic Sourcing Partner
Teva Pharmaceuticals
267-619-2132
Mauro.dipalo@tevapharm.com