Title: Senior Director, Head of Medical Derm
Sun Pharma, Princeton, New Jersey
Senior Director, Medical Affairs – Medical Dermatology (Office Based)
Sun Pharmaceuticals Industries Inc. is the fourth largest generic pharmaceutical company in the world, and rapidly building our brand presence. We manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories.
At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values: Humility. Integrity. Passion. Innovation
This position is located in Princeton, New Jersey - Hybrid work week (3 days in office; 2 days remote)
Summary:
The incumbent will work report to the VP, Medical Affairs, and be a key medical resource in developing and implementing the medical affairs strategy for clascoterone, acne, alopecia and other assets and disease states that may be added. He/she will be responsible for the coordination of several medical activities linked to clascoterone, acne, alopecia and other assets and disease states that may be added, in conjunction with the VP, Medical Affairs. Among the responsibilities, the incumbent will actively participate in preparation and implementation of medical advisory boards, co-manage the phase IV clinical trials program with the clinical development leader, chair the investigator sponsored studies (ISS) team, help define strategies and tactics to support medical education programs, review medical and scientific content of promotional materials, maintain KOL relationships and serve as a consultant for Marketing, Health Outcomes, Access, Marketing & Sales, and participate in the development of medical strategies to appropriately position clascoterone, acne, alopecia and other assets and disease states that may be added, as part of the Sun biologics portfolio. The incumbent will also oversee the dermatology medical science liaison team.
Responsibilities:
This position reports directly to the VP, Medical Affairs North America, and will manage multiple internal relationships within Sun Pharma. He/she will play a key role in external relationships include expert advisory board members, ISS investigators, patient advocacy groups, other consultants and key customer groups. He/she will contribute to the annual medical affairs plan strategic and tactical implementation for clascoterone, acne, alopecia and other assets and disease states that may be added.
A. Communications/Training
Responsible for the creation of educational curricula to effectively teach and assist in the training of sales representative, Drug Information specialists, and field MSLs
In conjunction with the VP, Medical Affairs, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions
Maintains required medical credentials and remains in good standing within the medical community and medical ethics boards
Stays abreast of regulatory requirements and guidelines and current trends and medical practice in the field of dermatology and immunology, including reports and intelligence on new technologies or treatment advances
B. Medical Communications
Responsible for developing medical education strategy (CME, medical grants, professional societies) specific to clascoterone, acne, alopecia and other assets and disease states that may be added, incorporating them into the medical affairs plans, and assesses their impact.
Participates in the development of publications strategy (primary, secondary, ad hoc and HEOR) specific to clascoterone, acne, alopecia and other assets and disease states that may be added, working closely with the publication lead.
Responsible for support of external medical educations programs (CME).
Responsible for promotional materials as a key member of the Medical-Regulatory-Legal review team, specific to clascoterone, acne, alopecia and other assets and disease states that may be added.
Supports Medical Information and Field MSLs training and governance
C. Regulatory/Safety Activities
Responsible for the ongoing safety and adequacy of labeling, from a medical perspective, of clascoterone, acne, alopecia and other assets and disease states that may be added.
Participates in the interpretation of regulatory guidelines and directives to judge risk and causality
Works closely with Clinical Development in selection of phase IIIb/IV investigators/sites, ensuring screening and accuracy, and guiding interpretation of results.
Assumes primary accountability as representative in Medical-Regulatory-Legal promotional team. This role requires full knowledge of various Federal and Pharma regulations and guidelines as well as in depth knowledge of the psoriasis disease state
Responsible for the medical definition and implementation of labeling strategies for clascoterone, acne, alopecia and other assets and disease states that may be added.
D. Sales/Marketing Support
Participates in presenting clinical data at regional and national advisory boards for clascoterone, acne, alopecia and other assets and disease states that may be added.
Responsible for providing medical input to market shaping strategy, marketing plans and promotional campaigns for clascoterone, acne, alopecia and other assets and disease states that may be added.
Responsible for medical input to commercial advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed
Participates in the development of medical product support and development plans in concert with Sales and Marketing for clascoterone, acne, alopecia and other assets and disease states that may be added.
Plays an active role in ongoing sales and marketing objectives by assisting in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees
Responsible for the quality and deliverables from Medical Information to assure that communication from Sun Pharma is scientifically accurate and clinically appropriate
STRATEGY AND PROTOCOL DEVELOPMENT
Participates in developing and executing phase IV trial strategy including prioritization criteria specific to clascoterone, acne, alopecia and other assets and disease states that may be added, and incorporates into the medical affairs plans, formalizing templates and processes to streamline protocol design, as well as developing specific ISS strategy, including prioritization criteria, and support execution.
Active participation in providing medical input on global clinical development plans for clascoterone, acne, alopecia and other assets and disease states that may be added.
Collaborates closely with the US HEOR group on activities (providing input into early economic models/endpoints, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications), and presenting this back to the medical affairs teams, related to clascoterone, acne, alopecia and other assets and disease states that may be added.
Helps build relationships and maintain a strong KOL network
Participates in discussions regarding local and global clinical trials
Participates in global publication planning for clascoterone, acne, alopecia and other assets and disease states that may be added.
Responsible for medical/scientific input into development and marketing strategies for clascoterone, acne, alopecia and other assets and disease states that may be added.
WORKPLACE REQUIREMENTS
Based in Princeton, NJ but able to travel 15-20% of the time. HYBRID work model - 3 days in office; 2 days remote
EDUCATION, EXPERIENCE, KNOWLEDGE and SKILLS
MD, PhD or PharmD
8 years or more of research or pharmaceutical industry experience, in the field of immunology and/or dermatology preferred, and able to manage direct reports
Strong strategic mindset, understanding of physician, patient and payer needs in a changing healthcare delivery environment
Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education)
Subspecialty training in dermatology, rheumatology or immunology preferred