In search of a physician career change opportunity or a new non-clinical career? A mid-sized pharmaceutical company in the Philadelphia area has asked an executive search firm to help them find a Director, Clinical R&D for their Coagulation products. This position is for an MD with a strong expertise in internal medicine, hematology, emergency medicine or any other discipline providing a sound clinical and experimental knowledge on clotting/bleeding disorders.
The purpose of the position is to lead the development of clinical strategies of company’s coagulation products for the management of perioperative bleeds. The position is also responsible for identifying clinical development plans for plasmatic and recombinant therapies used to treat hereditary coagulation deficiencies. The position holder will also work closely with the Clinical Director of coagulation and critical care in Europe or any other company sites were the need for the development of a coagulation/ critical care strategy arises.
Key factors in this position are: Deep knowledge of current needs, practice and therapeutic trends in the treatment of bleeding and coagulation disorders. Competent interaction with key-opinion leaders. Team-work and communication. Sound scientific methodology to address complex questions. The ability to bridge medical scientific and commercial needs. Competent interaction with senior management team.
This position is needed to obtain the necessary understanding of the North American market in the coagulation/critical care environment and align this knowledge with the global understanding that company is aiming for in the field.
Reports to: Head of Clinical Research and Development, US
Direct Reports: Currently None
Main Responsibilities and Accountabilities:
* Rapidly establish credibility for yourself with the Key Opinion Leaders, and with colleagues within the company. Gain an in-depth understanding of the product portfolio in the market and in development.
* Develop clinical strategies to support company´s coagulation products for the management of perioperative bleeds and leading to increased use in the field.
* Take responsibility for deciding on medical/therapeutic concepts applied in Phase I-III/IV studies to regulatory agencies. Focus is the identification and implementation of medical/clinical aspects in clinical trial design to achieve desired label claims under consideration of therapeutic practice and regulatory requirements in target indications.
* Advise Senior Management on medical aspects of product development and, through participation in senior decision-making committees, contribute to the selection of product candidates or novel indications for development.
* Collaborate closely with Preclinical Development on the selection of appropriate animal models to support clinical development strategies. Extensive preclinical expertise and state-of-the-art animal facilities are available on-site.
* You will have a leading role in enhancing company’s clinical and scientific reputation with regulatory agencies and key opinion leaders and you will interact closely with key opinion leaders through advisory boards or congresses to identify opportunities for new clinical indications and to influence clinical practice.
* Collaborate closely with Commercial Operations to assure alignment of clinical development programs with commercial strategies. You will also support Commercial Operations for publication planning and evaluation of Phase IV Investigator-led studies, and contribute on behalf of R&D to Global Business Teams.
Education
MD with a strong expertise in internal medicine, hematology, emergency medicine or any other discipline providing a sound clinical and experimental knowledge on clotting/bleeding disorders.
Experience
* At least 5 years experience in the pharmaceutical industry with a strong working knowledge of clinical and regulatory development processes (including cGMP and cGCP).
* Experience in clinical research and drug development either as investigator or in pharmaceutical industry is essential.
* Experience in the treatment of patients with coagulation disorders would be highly desirable.
* Demonstrated ability to collaborate with key clinical physicians and academics.
* Experience in the biopharmaceutical industry with a working knowledge of regulatory development processes is desirable.
Competencies
* Strong leadership and communication skills with both practical and strategic vision with internal and external customers.
* Work across multiple disciplines, including clinical, scientific, regulatory and commercial groups of the company as well as external institutions academic and non-academic
* Exhibits strong negotiation skills and is able to identify and engage internal and external expertise as needed.
* An excellent communicator both inside and outside the company. The ability to present to the senior executive team that has a very good medical knowledge of coagulation and contains many MDs with strong opinions.
* An open-minded leader with a global outlook who will win the respect of people across the businesses.
* Ability to a work successfully in a matrix organization and across multiple disciplines, including clinical, regulatory, and commercial management.
* Cultural sensitivity gained from experiences within diverse health care environments.
* A team player, first and foremost. Someone who is prepared to work hard and to support others.
* Results oriented, a person who knows that output counts.
* Integrity, passion, and the enthusiasm to contribute to the creation of the best coagulation company in the world.
* Independently minded and focused – able to take decisions around structures and people, and professional and supportive in driving through change. Someone who will be effective in an open and challenging culture
If you are interested in this position, please send a cover letter and CV to info at prnresource.com and we will apss it along to the search firm looking to fill the position.
SR 12-18
