Senior Director, Clinical Development Sciences Neurology

Alexion Pharmaceuticals, Inc. Boston , MA 02298

Posted 2 months ago

Position Summary

The Senior Director, Clinical Sciences will provide medical input to Global Program Teams (GPTs), serve as medical expert for the study team and medical monitor for phase 1-4 clinical trials.

The Senior Director is typically responsible for 1 or more medium sized clinical development programs under the supervision of either an Executive Director or a VP Clinical Development TA Head. In addition, she/he may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target) and/or contribute to other programs.

This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

Job Duties & Responsibilities

  • Medical input to the Global Development Team / Subteam

  • Medical Expert for clinical study team

  • Protocol development from concept to final protocol

  • Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring

  • Scientific interpretation of data from clinical studies

  • May supervise other medical monitors on individual studies

  • Strategic guidance to phase I/II/III development programs and oversight of global clinical trials/trial team (s) on assigned programs

  • Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management

  • Presentation at academic congresses, investigator meetings and advisory meetings

  • Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents

  • Providing medical/scientific input to evaluate potential business opportunities

Essential Qualifications

  • MD or equivalent; Board Certification preferred

  • 5-10 years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)

  • Experience as a medical monitor for clinical trials required

  • Regulatory experience preferred

  • Publication in peer reviewed journals

  • Excellent written / oral communication skills

  • Attention to detail and ability to think strategically

  • Willingness to take on new responsibilities

  • Interest and ability to learn about new therapeutic areas

  • Interest in career progression and ability to take on a more senior roles in 1-3 years

Preferred Qualifications

  • Experience for medical responsibilities on a cross-functional team preferred

  • Basic statistical knowledge preferred

  • LI-MW1

Boston, MA, United States

Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.

Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Executive Administrative Director I Neurology Services/Foundation

Children's Hospital Boston

Posted 3 days ago

VIEW JOBS 4/19/2019 12:00:00 AM 2019-07-18T00:00 Job Posting Description At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Neurology Department and discover how your talents can change lives. Yours included. This Executive Administrative Director I- Neurology will be responsible for: * Managing the strategic development and fiscal oversight of the clinical department at Boston Children's Hospital as well as a foundation and/or special hospital-based service fund. * Overseeing administrative and financial operations; medical staff appointments; applicable budgets; billing; and compliance with hospital, state and federal regulatory policies and procedures. This position jointly reports to the Chief of Service/ Foundation President and BCH Vice President. To qualify, you must have: * A Bachelor's degree is required. Master's is strongly preferred in Business, Public Health or Health Care Administration and 10 plus years of relevant experience. * Analytical skills to resolve highly complex problems requiring the application of scientific or technical principles, theories and concepts and in depth cross functional experienced based knowledge. * The ability to communicate both orally and written, in order to effectively deal with conflicting views or issues and mediating fair and workable solutions. * Identifying and resolving important, ethical, strategic and operational problems that require innovative solutions based on extensive knowledge of the health care industry. * Ability to effectively manage the employees within assigned unit/department and to influence and negotiate with peer level managers on issues and programs that impact assigned unit/department. Boston Children's Hospital offers competitive compensation and unmatched benefits, including an affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, cell phone plan discounts and discounted rates on T-passes (50% off). Discover your best. Boston Children's Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability. Children's Hospital Boston Boston MA

Senior Director, Clinical Development Sciences Neurology

Alexion Pharmaceuticals, Inc.